Doug Brunk

NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with type 2 diabetes, regardless of their renal function, results from a large post hoc meta-analysis showed.

The EDITION I, II, and III studies showed that over a period of 6 months, Gla-300 provided comparable glycemic control to Gla-100 with less hypoglycemia in patients with type 2 diabetes. However, “renal impairment increases the risk of hypoglycemia in people with type 2 diabetes, and may limit glucose-lowering therapy options,” Javier Escalada, M.D., said at the annual scientific sessions of the American Diabetes Association. “Therefore, it may be more challenging to manage diabetes in this population than in people with normal renal function.”

Dr. Escalada of the department of endocrinology and nutrition at Clinic University of Navarra, Pamplona, Spain, and his associates set out to investigate the impact of renal function on hemoglobin A_1c reduction and hypoglycemia in a post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies. Treatment consisted of once-daily evening doses of Gla-300 or Gla-100 titrated to a fasting self-measured plasma glucose of 80-100 mg/dL. Patients were classified by their renal function as having moderate loss (30 to less than 60 mL/min per 1.73 m³; 399 patients), mild loss (60 to less than 90; 1,386 patients), or normal function (at least 90; 683 patients).

Outcomes of interest were change in HbA_1c from baseline to month 6, and the percentages of patients achieving an HbA_1c target of lower than 7.0% and lower than 7.5% at month 6. The researchers also assessed the cumulative number of hypoglycemic events, the relative risk of at least one confirmed or severe hypoglycemic event, and the nocturnal and at any time event rate per participant year.

Slightly more than half of participants (56%) had a baseline estimated glomerular filtration rate of 60 to less than 90 mL/min per 1.73 m³. Dr. Escalada reported that noninferiority for HbA1c reduction was shown for Gla-300 and Gla-100 regardless of renal function, and that evidence of heterogeneity of treatment effect across subgroups was observed (P = .46). However, the risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group. Renal function did not affect the lower rate of nocturnal or anytime hypoglycemia. “Severe hypoglycemia was rare, and renal function did not affect the rate of severe events,” he said.

The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.

NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with type 2 diabetes, regardless of their renal function, results from a large post hoc meta-analysis showed.

The EDITION I, II, and III studies showed that over a period of 6 months, Gla-300 provided comparable glycemic control to Gla-100 with less hypoglycemia in patients with type 2 diabetes. However, “renal impairment increases the risk of hypoglycemia in people with type 2 diabetes, and may limit glucose-lowering therapy options,” Javier Escalada, M.D., said at the annual scientific sessions of the American Diabetes Association. “Therefore, it may be more challenging to manage diabetes in this population than in people with normal renal function.”

Dr. Escalada of the department of endocrinology and nutrition at Clinic University of Navarra, Pamplona, Spain, and his associates set out to investigate the impact of renal function on hemoglobin A_1c reduction and hypoglycemia in a post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies. Treatment consisted of once-daily evening doses of Gla-300 or Gla-100 titrated to a fasting self-measured plasma glucose of 80-100 mg/dL. Patients were classified by their renal function as having moderate loss (30 to less than 60 mL/min per 1.73 m³; 399 patients), mild loss (60 to less than 90; 1,386 patients), or normal function (at least 90; 683 patients).

Outcomes of interest were change in HbA_1c from baseline to month 6, and the percentages of patients achieving an HbA_1c target of lower than 7.0% and lower than 7.5% at month 6. The researchers also assessed the cumulative number of hypoglycemic events, the relative risk of at least one confirmed or severe hypoglycemic event, and the nocturnal and at any time event rate per participant year.

Slightly more than half of participants (56%) had a baseline estimated glomerular filtration rate of 60 to less than 90 mL/min per 1.73 m³. Dr. Escalada reported that noninferiority for HbA1c reduction was shown for Gla-300 and Gla-100 regardless of renal function, and that evidence of heterogeneity of treatment effect across subgroups was observed (P = .46). However, the risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group. Renal function did not affect the lower rate of nocturnal or anytime hypoglycemia. “Severe hypoglycemia was rare, and renal function did not affect the rate of severe events,” he said.

The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.

NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with type 2 diabetes, regardless of their renal function, results from a large post hoc meta-analysis showed.

The EDITION I, II, and III studies showed that over a period of 6 months, Gla-300 provided comparable glycemic control to Gla-100 with less hypoglycemia in patients with type 2 diabetes. However, “renal impairment increases the risk of hypoglycemia in people with type 2 diabetes, and may limit glucose-lowering therapy options,” Javier Escalada, M.D., said at the annual scientific sessions of the American Diabetes Association. “Therefore, it may be more challenging to manage diabetes in this population than in people with normal renal function.”

Dr. Escalada of the department of endocrinology and nutrition at Clinic University of Navarra, Pamplona, Spain, and his associates set out to investigate the impact of renal function on hemoglobin A_1c reduction and hypoglycemia in a post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies. Treatment consisted of once-daily evening doses of Gla-300 or Gla-100 titrated to a fasting self-measured plasma glucose of 80-100 mg/dL. Patients were classified by their renal function as having moderate loss (30 to less than 60 mL/min per 1.73 m³; 399 patients), mild loss (60 to less than 90; 1,386 patients), or normal function (at least 90; 683 patients).

Outcomes of interest were change in HbA_1c from baseline to month 6, and the percentages of patients achieving an HbA_1c target of lower than 7.0% and lower than 7.5% at month 6. The researchers also assessed the cumulative number of hypoglycemic events, the relative risk of at least one confirmed or severe hypoglycemic event, and the nocturnal and at any time event rate per participant year.

Slightly more than half of participants (56%) had a baseline estimated glomerular filtration rate of 60 to less than 90 mL/min per 1.73 m³. Dr. Escalada reported that noninferiority for HbA1c reduction was shown for Gla-300 and Gla-100 regardless of renal function, and that evidence of heterogeneity of treatment effect across subgroups was observed (P = .46). However, the risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group. Renal function did not affect the lower rate of nocturnal or anytime hypoglycemia. “Severe hypoglycemia was rare, and renal function did not affect the rate of severe events,” he said.

The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.

NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with type 2 diabetes, regardless of their renal function, results from a large post hoc meta-analysis showed.

The EDITION I, II, and III studies showed that over a period of 6 months, Gla-300 provided comparable glycemic control to Gla-100 with less hypoglycemia in patients with type 2 diabetes. However, “renal impairment increases the risk of hypoglycemia in people with type 2 diabetes, and may limit glucose-lowering therapy options,” Javier Escalada, M.D., said at the annual scientific sessions of the American Diabetes Association. “Therefore, it may be more challenging to manage diabetes in this population than in people with normal renal function.”

Dr. Escalada of the department of endocrinology and nutrition at Clinic University of Navarra, Pamplona, Spain, and his associates set out to investigate the impact of renal function on hemoglobin A_1c reduction and hypoglycemia in a post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies. Treatment consisted of once-daily evening doses of Gla-300 or Gla-100 titrated to a fasting self-measured plasma glucose of 80-100 mg/dL. Patients were classified by their renal function as having moderate loss (30 to less than 60 mL/min per 1.73 m³; 399 patients), mild loss (60 to less than 90; 1,386 patients), or normal function (at least 90; 683 patients).

Outcomes of interest were change in HbA_1c from baseline to month 6, and the percentages of patients achieving an HbA_1c target of lower than 7.0% and lower than 7.5% at month 6. The researchers also assessed the cumulative number of hypoglycemic events, the relative risk of at least one confirmed or severe hypoglycemic event, and the nocturnal and at any time event rate per participant year.

Slightly more than half of participants (56%) had a baseline estimated glomerular filtration rate of 60 to less than 90 mL/min per 1.73 m³. Dr. Escalada reported that noninferiority for HbA1c reduction was shown for Gla-300 and Gla-100 regardless of renal function, and that evidence of heterogeneity of treatment effect across subgroups was observed (P = .46). However, the risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group. Renal function did not affect the lower rate of nocturnal or anytime hypoglycemia. “Severe hypoglycemia was rare, and renal function did not affect the rate of severe events,” he said.

The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.

[email protected]

NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with type 2 diabetes, regardless of their renal function, results from a large post hoc meta-analysis showed.

The EDITION I, II, and III studies showed that over a period of 6 months, Gla-300 provided comparable glycemic control to Gla-100 with less hypoglycemia in patients with type 2 diabetes. However, “renal impairment increases the risk of hypoglycemia in people with type 2 diabetes, and may limit glucose-lowering therapy options,” Javier Escalada, M.D., said at the annual scientific sessions of the American Diabetes Association. “Therefore, it may be more challenging to manage diabetes in this population than in people with normal renal function.”

Dr. Escalada of the department of endocrinology and nutrition at Clinic University of Navarra, Pamplona, Spain, and his associates set out to investigate the impact of renal function on hemoglobin A_1c reduction and hypoglycemia in a post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies. Treatment consisted of once-daily evening doses of Gla-300 or Gla-100 titrated to a fasting self-measured plasma glucose of 80-100 mg/dL. Patients were classified by their renal function as having moderate loss (30 to less than 60 mL/min per 1.73 m³; 399 patients), mild loss (60 to less than 90; 1,386 patients), or normal function (at least 90; 683 patients).

Outcomes of interest were change in HbA_1c from baseline to month 6, and the percentages of patients achieving an HbA_1c target of lower than 7.0% and lower than 7.5% at month 6. The researchers also assessed the cumulative number of hypoglycemic events, the relative risk of at least one confirmed or severe hypoglycemic event, and the nocturnal and at any time event rate per participant year.

Slightly more than half of participants (56%) had a baseline estimated glomerular filtration rate of 60 to less than 90 mL/min per 1.73 m³. Dr. Escalada reported that noninferiority for HbA1c reduction was shown for Gla-300 and Gla-100 regardless of renal function, and that evidence of heterogeneity of treatment effect across subgroups was observed (P = .46). However, the risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group. Renal function did not affect the lower rate of nocturnal or anytime hypoglycemia. “Severe hypoglycemia was rare, and renal function did not affect the rate of severe events,” he said.

The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.

[email protected]

NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with type 2 diabetes, regardless of their renal function, results from a large post hoc meta-analysis showed.

The EDITION I, II, and III studies showed that over a period of 6 months, Gla-300 provided comparable glycemic control to Gla-100 with less hypoglycemia in patients with type 2 diabetes. However, “renal impairment increases the risk of hypoglycemia in people with type 2 diabetes, and may limit glucose-lowering therapy options,” Javier Escalada, M.D., said at the annual scientific sessions of the American Diabetes Association. “Therefore, it may be more challenging to manage diabetes in this population than in people with normal renal function.”

Dr. Escalada of the department of endocrinology and nutrition at Clinic University of Navarra, Pamplona, Spain, and his associates set out to investigate the impact of renal function on hemoglobin A_1c reduction and hypoglycemia in a post hoc meta-analysis of 2,468 patients aged 18 years and older with type 2 diabetes who were treated with Gla-300 or Gla-100 for 6 months in the EDITION I, II, and III studies. Treatment consisted of once-daily evening doses of Gla-300 or Gla-100 titrated to a fasting self-measured plasma glucose of 80-100 mg/dL. Patients were classified by their renal function as having moderate loss (30 to less than 60 mL/min per 1.73 m³; 399 patients), mild loss (60 to less than 90; 1,386 patients), or normal function (at least 90; 683 patients).

Outcomes of interest were change in HbA_1c from baseline to month 6, and the percentages of patients achieving an HbA_1c target of lower than 7.0% and lower than 7.5% at month 6. The researchers also assessed the cumulative number of hypoglycemic events, the relative risk of at least one confirmed or severe hypoglycemic event, and the nocturnal and at any time event rate per participant year.

Slightly more than half of participants (56%) had a baseline estimated glomerular filtration rate of 60 to less than 90 mL/min per 1.73 m³. Dr. Escalada reported that noninferiority for HbA1c reduction was shown for Gla-300 and Gla-100 regardless of renal function, and that evidence of heterogeneity of treatment effect across subgroups was observed (P = .46). However, the risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events in the Gla-300 group, compared with the Gla-100 group (30% vs. 40% overall, respectively), while the risk of anytime hypoglycemia events in a 24-hour period was comparable to or lower in the Gla-300 group, compared with the Gla-100 group. Renal function did not affect the lower rate of nocturnal or anytime hypoglycemia. “Severe hypoglycemia was rare, and renal function did not affect the rate of severe events,” he said.

The trial was sponsored by Sanofi. Dr. Escalada disclosed that he is a member of the advisory panel for Sanofi and for Merck Sharp & Dohme. He is also a member of the speakers bureau for both companies as well as for AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.

[email protected]

NEW ORLEANS – The addition of dapagliflozin to insulin and liraglutide in patients with type 1 diabetes resulted in a significant improvement in glycemia, results from a single-center randomized trial showed.

“Because liraglutide suppresses glucagon and lowers free fatty acids while SGLT-2 inhibitors increase glucagon and risk of diabetic ketoacidosis, it’s possible that the combination of the two agents may neutralize the diabetic ketoacidosis risk,” Paresh Dandona, MD, said at the annual scientific sessions of the American Diabetes Association.

In a recent study Dr. Dandona, chief of endocrinology at the University of Buffalo (N.Y.), and his associates showed that the addition of liraglutide to insulin significantly improved glycemic control in patients with type 1 diabetes (Diabetes Care 2016 Jun; 39[6]:1027-35). The purpose of the current study was to investigate whether the addition of dapagliflozin, a sodium-glucose cotransporter–2 inhibitor, to the combination of insulin and liraglutide would further improve glycemic control.

A total of 30 type 1 diabetes patients on insulin and liraglutide therapy for a minimum of 6 months were randomized to receive either dapagliflozin 10 mg or placebo daily for 12 weeks. Dapagliflozin was initiated at 5 mg daily for 1 week and increased to 10 mg daily thereafter. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, had no detectable C-peptide in plasma, and were on 1.8 mg of liraglutide for 7 months. These patients were evaluated every week for the first and last 2 weeks and then every 2 weeks for 12 weeks. Blood and 24-hour urine samples were collected before and after intervention.

At baseline, the mean age of patients was 54 years and both groups were similar in terms of mean hemoglobin A_1c, glucose levels, and insulin dosages. After 12 weeks, the mean HbA_1c did not change in the placebo group, but it dropped significantly in the triple-therapy group, by .66% (P less than .01). In addition, the average weekly glucose concentration fell in the triple-therapy group by 13 mg/dL (P = .35) and there was a reduction in standard deviations of glycemic excursions. The triple-therapy group also experienced a small reduction in the total insulin dose, compared with the placebo group (–3.5 vs. –.4 units, respectively; P = .29)

Dr. Dandona went on to note that the episodes of hypoglycemia did not increase after triple therapy but body weight fell by 1.9 kg after 12 weeks, while there was no real change in the placebo arm. Two patients had to withdraw from the study because they developed diabetic ketoacidosis within a day after increasing the dose of dapagliflozin to 10 mg. “One of these patients had euglycemic DKA with blood glucose concentrations of less than 160 mg/dL, while the other had marked hyperglycemia with unchanged insulin dose at 26 units,” Dr. Dandona said. “This patient had experienced a marked reduction in insulin dose during the time she was on liraglutide prior to starting on dapagliflozin.”

Dr. Dandona disclosed that he has received research support from AstraZeneca and Novo Nordisk.

NEW ORLEANS – The addition of dapagliflozin to insulin and liraglutide in patients with type 1 diabetes resulted in a significant improvement in glycemia, results from a single-center randomized trial showed.

“Because liraglutide suppresses glucagon and lowers free fatty acids while SGLT-2 inhibitors increase glucagon and risk of diabetic ketoacidosis, it’s possible that the combination of the two agents may neutralize the diabetic ketoacidosis risk,” Paresh Dandona, MD, said at the annual scientific sessions of the American Diabetes Association.

In a recent study Dr. Dandona, chief of endocrinology at the University of Buffalo (N.Y.), and his associates showed that the addition of liraglutide to insulin significantly improved glycemic control in patients with type 1 diabetes (Diabetes Care 2016 Jun; 39[6]:1027-35). The purpose of the current study was to investigate whether the addition of dapagliflozin, a sodium-glucose cotransporter–2 inhibitor, to the combination of insulin and liraglutide would further improve glycemic control.

A total of 30 type 1 diabetes patients on insulin and liraglutide therapy for a minimum of 6 months were randomized to receive either dapagliflozin 10 mg or placebo daily for 12 weeks. Dapagliflozin was initiated at 5 mg daily for 1 week and increased to 10 mg daily thereafter. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, had no detectable C-peptide in plasma, and were on 1.8 mg of liraglutide for 7 months. These patients were evaluated every week for the first and last 2 weeks and then every 2 weeks for 12 weeks. Blood and 24-hour urine samples were collected before and after intervention.

At baseline, the mean age of patients was 54 years and both groups were similar in terms of mean hemoglobin A_1c, glucose levels, and insulin dosages. After 12 weeks, the mean HbA_1c did not change in the placebo group, but it dropped significantly in the triple-therapy group, by .66% (P less than .01). In addition, the average weekly glucose concentration fell in the triple-therapy group by 13 mg/dL (P = .35) and there was a reduction in standard deviations of glycemic excursions. The triple-therapy group also experienced a small reduction in the total insulin dose, compared with the placebo group (–3.5 vs. –.4 units, respectively; P = .29)

Dr. Dandona went on to note that the episodes of hypoglycemia did not increase after triple therapy but body weight fell by 1.9 kg after 12 weeks, while there was no real change in the placebo arm. Two patients had to withdraw from the study because they developed diabetic ketoacidosis within a day after increasing the dose of dapagliflozin to 10 mg. “One of these patients had euglycemic DKA with blood glucose concentrations of less than 160 mg/dL, while the other had marked hyperglycemia with unchanged insulin dose at 26 units,” Dr. Dandona said. “This patient had experienced a marked reduction in insulin dose during the time she was on liraglutide prior to starting on dapagliflozin.”

Dr. Dandona disclosed that he has received research support from AstraZeneca and Novo Nordisk.

NEW ORLEANS – The addition of dapagliflozin to insulin and liraglutide in patients with type 1 diabetes resulted in a significant improvement in glycemia, results from a single-center randomized trial showed.

“Because liraglutide suppresses glucagon and lowers free fatty acids while SGLT-2 inhibitors increase glucagon and risk of diabetic ketoacidosis, it’s possible that the combination of the two agents may neutralize the diabetic ketoacidosis risk,” Paresh Dandona, MD, said at the annual scientific sessions of the American Diabetes Association.

In a recent study Dr. Dandona, chief of endocrinology at the University of Buffalo (N.Y.), and his associates showed that the addition of liraglutide to insulin significantly improved glycemic control in patients with type 1 diabetes (Diabetes Care 2016 Jun; 39[6]:1027-35). The purpose of the current study was to investigate whether the addition of dapagliflozin, a sodium-glucose cotransporter–2 inhibitor, to the combination of insulin and liraglutide would further improve glycemic control.

A total of 30 type 1 diabetes patients on insulin and liraglutide therapy for a minimum of 6 months were randomized to receive either dapagliflozin 10 mg or placebo daily for 12 weeks. Dapagliflozin was initiated at 5 mg daily for 1 week and increased to 10 mg daily thereafter. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, had no detectable C-peptide in plasma, and were on 1.8 mg of liraglutide for 7 months. These patients were evaluated every week for the first and last 2 weeks and then every 2 weeks for 12 weeks. Blood and 24-hour urine samples were collected before and after intervention.

At baseline, the mean age of patients was 54 years and both groups were similar in terms of mean hemoglobin A_1c, glucose levels, and insulin dosages. After 12 weeks, the mean HbA_1c did not change in the placebo group, but it dropped significantly in the triple-therapy group, by .66% (P less than .01). In addition, the average weekly glucose concentration fell in the triple-therapy group by 13 mg/dL (P = .35) and there was a reduction in standard deviations of glycemic excursions. The triple-therapy group also experienced a small reduction in the total insulin dose, compared with the placebo group (–3.5 vs. –.4 units, respectively; P = .29)

Dr. Dandona went on to note that the episodes of hypoglycemia did not increase after triple therapy but body weight fell by 1.9 kg after 12 weeks, while there was no real change in the placebo arm. Two patients had to withdraw from the study because they developed diabetic ketoacidosis within a day after increasing the dose of dapagliflozin to 10 mg. “One of these patients had euglycemic DKA with blood glucose concentrations of less than 160 mg/dL, while the other had marked hyperglycemia with unchanged insulin dose at 26 units,” Dr. Dandona said. “This patient had experienced a marked reduction in insulin dose during the time she was on liraglutide prior to starting on dapagliflozin.”

Dr. Dandona disclosed that he has received research support from AstraZeneca and Novo Nordisk.

NEW ORLEANS – The addition of dapagliflozin to insulin and liraglutide in patients with type 1 diabetes resulted in a significant improvement in glycemia, results from a single-center randomized trial showed.

“Because liraglutide suppresses glucagon and lowers free fatty acids while SGLT-2 inhibitors increase glucagon and risk of diabetic ketoacidosis, it’s possible that the combination of the two agents may neutralize the diabetic ketoacidosis risk,” Paresh Dandona, MD, said at the annual scientific sessions of the American Diabetes Association.

In a recent study Dr. Dandona, chief of endocrinology at the University of Buffalo (N.Y.), and his associates showed that the addition of liraglutide to insulin significantly improved glycemic control in patients with type 1 diabetes (Diabetes Care 2016 Jun; 39[6]:1027-35). The purpose of the current study was to investigate whether the addition of dapagliflozin, a sodium-glucose cotransporter–2 inhibitor, to the combination of insulin and liraglutide would further improve glycemic control.

A total of 30 type 1 diabetes patients on insulin and liraglutide therapy for a minimum of 6 months were randomized to receive either dapagliflozin 10 mg or placebo daily for 12 weeks. Dapagliflozin was initiated at 5 mg daily for 1 week and increased to 10 mg daily thereafter. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, had no detectable C-peptide in plasma, and were on 1.8 mg of liraglutide for 7 months. These patients were evaluated every week for the first and last 2 weeks and then every 2 weeks for 12 weeks. Blood and 24-hour urine samples were collected before and after intervention.

At baseline, the mean age of patients was 54 years and both groups were similar in terms of mean hemoglobin A_1c, glucose levels, and insulin dosages. After 12 weeks, the mean HbA_1c did not change in the placebo group, but it dropped significantly in the triple-therapy group, by .66% (P less than .01). In addition, the average weekly glucose concentration fell in the triple-therapy group by 13 mg/dL (P = .35) and there was a reduction in standard deviations of glycemic excursions. The triple-therapy group also experienced a small reduction in the total insulin dose, compared with the placebo group (–3.5 vs. –.4 units, respectively; P = .29)

Dr. Dandona went on to note that the episodes of hypoglycemia did not increase after triple therapy but body weight fell by 1.9 kg after 12 weeks, while there was no real change in the placebo arm. Two patients had to withdraw from the study because they developed diabetic ketoacidosis within a day after increasing the dose of dapagliflozin to 10 mg. “One of these patients had euglycemic DKA with blood glucose concentrations of less than 160 mg/dL, while the other had marked hyperglycemia with unchanged insulin dose at 26 units,” Dr. Dandona said. “This patient had experienced a marked reduction in insulin dose during the time she was on liraglutide prior to starting on dapagliflozin.”

Dr. Dandona disclosed that he has received research support from AstraZeneca and Novo Nordisk.

[email protected]

NEW ORLEANS – The addition of dapagliflozin to insulin and liraglutide in patients with type 1 diabetes resulted in a significant improvement in glycemia, results from a single-center randomized trial showed.

“Because liraglutide suppresses glucagon and lowers free fatty acids while SGLT-2 inhibitors increase glucagon and risk of diabetic ketoacidosis, it’s possible that the combination of the two agents may neutralize the diabetic ketoacidosis risk,” Paresh Dandona, MD, said at the annual scientific sessions of the American Diabetes Association.

In a recent study Dr. Dandona, chief of endocrinology at the University of Buffalo (N.Y.), and his associates showed that the addition of liraglutide to insulin significantly improved glycemic control in patients with type 1 diabetes (Diabetes Care 2016 Jun; 39[6]:1027-35). The purpose of the current study was to investigate whether the addition of dapagliflozin, a sodium-glucose cotransporter–2 inhibitor, to the combination of insulin and liraglutide would further improve glycemic control.

A total of 30 type 1 diabetes patients on insulin and liraglutide therapy for a minimum of 6 months were randomized to receive either dapagliflozin 10 mg or placebo daily for 12 weeks. Dapagliflozin was initiated at 5 mg daily for 1 week and increased to 10 mg daily thereafter. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, had no detectable C-peptide in plasma, and were on 1.8 mg of liraglutide for 7 months. These patients were evaluated every week for the first and last 2 weeks and then every 2 weeks for 12 weeks. Blood and 24-hour urine samples were collected before and after intervention.

At baseline, the mean age of patients was 54 years and both groups were similar in terms of mean hemoglobin A_1c, glucose levels, and insulin dosages. After 12 weeks, the mean HbA_1c did not change in the placebo group, but it dropped significantly in the triple-therapy group, by .66% (P less than .01). In addition, the average weekly glucose concentration fell in the triple-therapy group by 13 mg/dL (P = .35) and there was a reduction in standard deviations of glycemic excursions. The triple-therapy group also experienced a small reduction in the total insulin dose, compared with the placebo group (–3.5 vs. –.4 units, respectively; P = .29)

Dr. Dandona went on to note that the episodes of hypoglycemia did not increase after triple therapy but body weight fell by 1.9 kg after 12 weeks, while there was no real change in the placebo arm. Two patients had to withdraw from the study because they developed diabetic ketoacidosis within a day after increasing the dose of dapagliflozin to 10 mg. “One of these patients had euglycemic DKA with blood glucose concentrations of less than 160 mg/dL, while the other had marked hyperglycemia with unchanged insulin dose at 26 units,” Dr. Dandona said. “This patient had experienced a marked reduction in insulin dose during the time she was on liraglutide prior to starting on dapagliflozin.”

Dr. Dandona disclosed that he has received research support from AstraZeneca and Novo Nordisk.

[email protected]

NEW ORLEANS – The addition of dapagliflozin to insulin and liraglutide in patients with type 1 diabetes resulted in a significant improvement in glycemia, results from a single-center randomized trial showed.

“Because liraglutide suppresses glucagon and lowers free fatty acids while SGLT-2 inhibitors increase glucagon and risk of diabetic ketoacidosis, it’s possible that the combination of the two agents may neutralize the diabetic ketoacidosis risk,” Paresh Dandona, MD, said at the annual scientific sessions of the American Diabetes Association.

In a recent study Dr. Dandona, chief of endocrinology at the University of Buffalo (N.Y.), and his associates showed that the addition of liraglutide to insulin significantly improved glycemic control in patients with type 1 diabetes (Diabetes Care 2016 Jun; 39[6]:1027-35). The purpose of the current study was to investigate whether the addition of dapagliflozin, a sodium-glucose cotransporter–2 inhibitor, to the combination of insulin and liraglutide would further improve glycemic control.

A total of 30 type 1 diabetes patients on insulin and liraglutide therapy for a minimum of 6 months were randomized to receive either dapagliflozin 10 mg or placebo daily for 12 weeks. Dapagliflozin was initiated at 5 mg daily for 1 week and increased to 10 mg daily thereafter. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, had no detectable C-peptide in plasma, and were on 1.8 mg of liraglutide for 7 months. These patients were evaluated every week for the first and last 2 weeks and then every 2 weeks for 12 weeks. Blood and 24-hour urine samples were collected before and after intervention.

At baseline, the mean age of patients was 54 years and both groups were similar in terms of mean hemoglobin A_1c, glucose levels, and insulin dosages. After 12 weeks, the mean HbA_1c did not change in the placebo group, but it dropped significantly in the triple-therapy group, by .66% (P less than .01). In addition, the average weekly glucose concentration fell in the triple-therapy group by 13 mg/dL (P = .35) and there was a reduction in standard deviations of glycemic excursions. The triple-therapy group also experienced a small reduction in the total insulin dose, compared with the placebo group (–3.5 vs. –.4 units, respectively; P = .29)

Dr. Dandona went on to note that the episodes of hypoglycemia did not increase after triple therapy but body weight fell by 1.9 kg after 12 weeks, while there was no real change in the placebo arm. Two patients had to withdraw from the study because they developed diabetic ketoacidosis within a day after increasing the dose of dapagliflozin to 10 mg. “One of these patients had euglycemic DKA with blood glucose concentrations of less than 160 mg/dL, while the other had marked hyperglycemia with unchanged insulin dose at 26 units,” Dr. Dandona said. “This patient had experienced a marked reduction in insulin dose during the time she was on liraglutide prior to starting on dapagliflozin.”

Dr. Dandona disclosed that he has received research support from AstraZeneca and Novo Nordisk.

[email protected]

NEW ORLEANS – Compared with placebo, canagliflozin improved glycemic control and reduced glycemic variability over 18 weeks in adults with type 1 diabetes that had been inadequately controlled with insulin, according to results from a randomized trial.

“Patients with type 1 diabetes can experience acute and profound glucose fluctuations, which may be related to variability in insulin activity and changes in day-to-day activities,” Maria Alba, MD, said at the annual scientific sessions of the American Diabetes Association. “A major challenge in the treatment of type 1 diabetes is achieving patient-specific glycemic control while avoiding episodes of hyperglycemia and hypoglycemia.”

Canagliflozin is a sodium glucose cotransporter 2 inhibitor approved for the treatment of type 2 diabetes; it lowers blood glucose through an insulin-dependent mechanism by lowering the renal threshold for glucose and increasing urinary glucose excretion. It is not approved for the treatment of type 1 diabetes. In a phase II study, canagliflozin improved glycemic control and provided reductions in body weight and insulin dose in patients with type 1 diabetes who were on background insulin over 18 weeks (Diabetes Care 2015;39[12]:2258-65).

The purpose of the current study was to assess the effects of canagliflozin on daily mean glucose, glycemic variability, and time spent in glycemic ranges (greater than 70-180 mg/dL) in adults with type 1 diabetes inadequately controlled with insulin therapy, said Dr. Alba of Janssen Research & Development, Raritan, N.J. In all, 351 patients were randomized to placebo or 100 mg or 300 mg of canagliflozin. All had had the disease for at least 1 year, had a baseline hemoglobin A_1c level between 7% and 9%, and had to be on a stable insulin regimen for at least 8 weeks. “On the day before randomization, patients were advised to reduce their basal insulin by 10% or 20%, depending on their baseline A_1c,” she said. “Once randomized, they were instructed to titrate their insulin to reach specific glycemic goals.”

All patients were to record 9-point self-monitoring blood glucose (SMBG) measurements throughout the study. Continuous glucose monitoring (CGM) assessments were performed at selected study centers in a substudy of 89 patients. Efficacy endpoints assessed by 9-point SMBG at week 18 were change from baseline in mean daily glucose and daily glucose standard deviation. Efficacy endpoints in the CGM substudy at week 18 were change from baseline in mean glucose, patterns of glucose variability, and time spent within target glucose (greater than 70-180 mg/dL), above target (greater than 180 mg/dL), or below target (70 mg/dL or less). The mean age of study participants was 43 years, 55% were male, and their mean baseline A_1c was 7.9%.

At 18 weeks, reductions in daily mean glucose were observed in the canagliflozin 100-mg and 300-mg groups, compared with placebo (–22.4 and –19.4 mg/dL, respectively, vs. a rise of 3 mg/dL in the placebo group), as well as reductions in daily glucose standard deviation (–16.4 and –18.1 mg/dL, vs. –1.9 mg/dL), Dr. Alba reported.

The researchers also found that the percentage of time spent within the glycemic target range was greater in the canagliflozin 100- and 300-mg groups, compared with placebo (a change from baseline of 11.6% and 10.1%, respectively, compared with a decrease of 3.5%), while the percentage of time spent above target was lower in both canagliflozin doses, compared with placebo. Canagliflozin was generally well tolerated, with a dose-dependent increase in ketone-related adverse events (5.1% in the 100-mg group and 9.4% in the 300-mg group).

Janssen Research & Development supported the study.

[email protected]

NEW ORLEANS – Compared with placebo, canagliflozin improved glycemic control and reduced glycemic variability over 18 weeks in adults with type 1 diabetes that had been inadequately controlled with insulin, according to results from a randomized trial.

“Patients with type 1 diabetes can experience acute and profound glucose fluctuations, which may be related to variability in insulin activity and changes in day-to-day activities,” Maria Alba, MD, said at the annual scientific sessions of the American Diabetes Association. “A major challenge in the treatment of type 1 diabetes is achieving patient-specific glycemic control while avoiding episodes of hyperglycemia and hypoglycemia.”

Canagliflozin is a sodium glucose cotransporter 2 inhibitor approved for the treatment of type 2 diabetes; it lowers blood glucose through an insulin-dependent mechanism by lowering the renal threshold for glucose and increasing urinary glucose excretion. It is not approved for the treatment of type 1 diabetes. In a phase II study, canagliflozin improved glycemic control and provided reductions in body weight and insulin dose in patients with type 1 diabetes who were on background insulin over 18 weeks (Diabetes Care 2015;39[12]:2258-65).

The purpose of the current study was to assess the effects of canagliflozin on daily mean glucose, glycemic variability, and time spent in glycemic ranges (greater than 70-180 mg/dL) in adults with type 1 diabetes inadequately controlled with insulin therapy, said Dr. Alba of Janssen Research & Development, Raritan, N.J. In all, 351 patients were randomized to placebo or 100 mg or 300 mg of canagliflozin. All had had the disease for at least 1 year, had a baseline hemoglobin A_1c level between 7% and 9%, and had to be on a stable insulin regimen for at least 8 weeks. “On the day before randomization, patients were advised to reduce their basal insulin by 10% or 20%, depending on their baseline A_1c,” she said. “Once randomized, they were instructed to titrate their insulin to reach specific glycemic goals.”

All patients were to record 9-point self-monitoring blood glucose (SMBG) measurements throughout the study. Continuous glucose monitoring (CGM) assessments were performed at selected study centers in a substudy of 89 patients. Efficacy endpoints assessed by 9-point SMBG at week 18 were change from baseline in mean daily glucose and daily glucose standard deviation. Efficacy endpoints in the CGM substudy at week 18 were change from baseline in mean glucose, patterns of glucose variability, and time spent within target glucose (greater than 70-180 mg/dL), above target (greater than 180 mg/dL), or below target (70 mg/dL or less). The mean age of study participants was 43 years, 55% were male, and their mean baseline A_1c was 7.9%.

At 18 weeks, reductions in daily mean glucose were observed in the canagliflozin 100-mg and 300-mg groups, compared with placebo (–22.4 and –19.4 mg/dL, respectively, vs. a rise of 3 mg/dL in the placebo group), as well as reductions in daily glucose standard deviation (–16.4 and –18.1 mg/dL, vs. –1.9 mg/dL), Dr. Alba reported.

The researchers also found that the percentage of time spent within the glycemic target range was greater in the canagliflozin 100- and 300-mg groups, compared with placebo (a change from baseline of 11.6% and 10.1%, respectively, compared with a decrease of 3.5%), while the percentage of time spent above target was lower in both canagliflozin doses, compared with placebo. Canagliflozin was generally well tolerated, with a dose-dependent increase in ketone-related adverse events (5.1% in the 100-mg group and 9.4% in the 300-mg group).

Janssen Research & Development supported the study.

[email protected]

NEW ORLEANS – Compared with placebo, canagliflozin improved glycemic control and reduced glycemic variability over 18 weeks in adults with type 1 diabetes that had been inadequately controlled with insulin, according to results from a randomized trial.

“Patients with type 1 diabetes can experience acute and profound glucose fluctuations, which may be related to variability in insulin activity and changes in day-to-day activities,” Maria Alba, MD, said at the annual scientific sessions of the American Diabetes Association. “A major challenge in the treatment of type 1 diabetes is achieving patient-specific glycemic control while avoiding episodes of hyperglycemia and hypoglycemia.”

Canagliflozin is a sodium glucose cotransporter 2 inhibitor approved for the treatment of type 2 diabetes; it lowers blood glucose through an insulin-dependent mechanism by lowering the renal threshold for glucose and increasing urinary glucose excretion. It is not approved for the treatment of type 1 diabetes. In a phase II study, canagliflozin improved glycemic control and provided reductions in body weight and insulin dose in patients with type 1 diabetes who were on background insulin over 18 weeks (Diabetes Care 2015;39[12]:2258-65).

The purpose of the current study was to assess the effects of canagliflozin on daily mean glucose, glycemic variability, and time spent in glycemic ranges (greater than 70-180 mg/dL) in adults with type 1 diabetes inadequately controlled with insulin therapy, said Dr. Alba of Janssen Research & Development, Raritan, N.J. In all, 351 patients were randomized to placebo or 100 mg or 300 mg of canagliflozin. All had had the disease for at least 1 year, had a baseline hemoglobin A_1c level between 7% and 9%, and had to be on a stable insulin regimen for at least 8 weeks. “On the day before randomization, patients were advised to reduce their basal insulin by 10% or 20%, depending on their baseline A_1c,” she said. “Once randomized, they were instructed to titrate their insulin to reach specific glycemic goals.”

All patients were to record 9-point self-monitoring blood glucose (SMBG) measurements throughout the study. Continuous glucose monitoring (CGM) assessments were performed at selected study centers in a substudy of 89 patients. Efficacy endpoints assessed by 9-point SMBG at week 18 were change from baseline in mean daily glucose and daily glucose standard deviation. Efficacy endpoints in the CGM substudy at week 18 were change from baseline in mean glucose, patterns of glucose variability, and time spent within target glucose (greater than 70-180 mg/dL), above target (greater than 180 mg/dL), or below target (70 mg/dL or less). The mean age of study participants was 43 years, 55% were male, and their mean baseline A_1c was 7.9%.

At 18 weeks, reductions in daily mean glucose were observed in the canagliflozin 100-mg and 300-mg groups, compared with placebo (–22.4 and –19.4 mg/dL, respectively, vs. a rise of 3 mg/dL in the placebo group), as well as reductions in daily glucose standard deviation (–16.4 and –18.1 mg/dL, vs. –1.9 mg/dL), Dr. Alba reported.

The researchers also found that the percentage of time spent within the glycemic target range was greater in the canagliflozin 100- and 300-mg groups, compared with placebo (a change from baseline of 11.6% and 10.1%, respectively, compared with a decrease of 3.5%), while the percentage of time spent above target was lower in both canagliflozin doses, compared with placebo. Canagliflozin was generally well tolerated, with a dose-dependent increase in ketone-related adverse events (5.1% in the 100-mg group and 9.4% in the 300-mg group).

Janssen Research & Development supported the study.

[email protected]

NEW ORLEANS – There is a high burden of early complications among young adults with type 1 or type 2 diabetes, results from an ongoing study demonstrated.

“We are witnessing a recent increase in type 2 diabetes in the pediatric U.S. population, paralleling a somewhat more established rise in type 1 diabetes among youth worldwide,” Dana Dabelea, MD, PhD, said at the annual scientific sessions of the American Diabetes Association. “In the face of this increasing disease burden, we are left with limited information on the consequences of having diabetes on these youth, specifically the burden of diabetes-related chronic complications. No study exists in the U.S. that is able to compare this burden in youth with type 2 versus those with type 1 diabetes. Prior studies elsewhere worldwide have used mostly medical records or administrative data, have small sample sizes, and include youth with variable disease duration.”

The aim of the current study was to assess and compare the prevalence of several complications in youth with either type 1 or type 2 diabetes of similar age and disease (short) duration, and to explore the potential risk factors for observed differences by diabetes type. Dr. Dabelea of the department of epidemiology at the University of Colorado School of Public Health in Denver, and her colleagues from the SEARCH for Diabetes in Youth Study, developed a cohort of 1,746 individuals with type 1 and 272 with type 2 diabetes, diagnosed when younger than age 20, assembled from the population-based SEARCH Registry in five U.S. sites, and registered upon diagnosis between 2002 and 2008. The most recent visit was between 2011 and 2015 when participants were at least 10 years of age.

Outcomes, measured once at the cohort visit between 2010 and 2015, included diabetic kidney disease, diabetic retinopathy, peripheral neuropathy, cardiovascular autonomic neuropathy, arterial stiffness, and hypertension.

Dr. Dabelea reported that 32% of youth with type 1 diabetes and 72% of those with type 2 diabetes had at least one early complication. For all complications, except cardiovascular autonomic neuropathy, the prevalence was significantly higher in those with type 2 diabetes, compared with those who had type 1 disease, with a similar pattern by race, especially for minority youth. Estimates were also usually higher within type among minority vs. non-white Hispanic youth, especially for type 2 diabetes. The findings “indicate a need for heightened clinical suspicion and detection of early complications, together with aggressive risk factor control, especially in type 2 diabetes and minority youth,” she concluded.

The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Dabelea reported having no financial disclosures.

[email protected]

NEW ORLEANS – There is a high burden of early complications among young adults with type 1 or type 2 diabetes, results from an ongoing study demonstrated.

“We are witnessing a recent increase in type 2 diabetes in the pediatric U.S. population, paralleling a somewhat more established rise in type 1 diabetes among youth worldwide,” Dana Dabelea, MD, PhD, said at the annual scientific sessions of the American Diabetes Association. “In the face of this increasing disease burden, we are left with limited information on the consequences of having diabetes on these youth, specifically the burden of diabetes-related chronic complications. No study exists in the U.S. that is able to compare this burden in youth with type 2 versus those with type 1 diabetes. Prior studies elsewhere worldwide have used mostly medical records or administrative data, have small sample sizes, and include youth with variable disease duration.”

The aim of the current study was to assess and compare the prevalence of several complications in youth with either type 1 or type 2 diabetes of similar age and disease (short) duration, and to explore the potential risk factors for observed differences by diabetes type. Dr. Dabelea of the department of epidemiology at the University of Colorado School of Public Health in Denver, and her colleagues from the SEARCH for Diabetes in Youth Study, developed a cohort of 1,746 individuals with type 1 and 272 with type 2 diabetes, diagnosed when younger than age 20, assembled from the population-based SEARCH Registry in five U.S. sites, and registered upon diagnosis between 2002 and 2008. The most recent visit was between 2011 and 2015 when participants were at least 10 years of age.

Outcomes, measured once at the cohort visit between 2010 and 2015, included diabetic kidney disease, diabetic retinopathy, peripheral neuropathy, cardiovascular autonomic neuropathy, arterial stiffness, and hypertension.

Dr. Dabelea reported that 32% of youth with type 1 diabetes and 72% of those with type 2 diabetes had at least one early complication. For all complications, except cardiovascular autonomic neuropathy, the prevalence was significantly higher in those with type 2 diabetes, compared with those who had type 1 disease, with a similar pattern by race, especially for minority youth. Estimates were also usually higher within type among minority vs. non-white Hispanic youth, especially for type 2 diabetes. The findings “indicate a need for heightened clinical suspicion and detection of early complications, together with aggressive risk factor control, especially in type 2 diabetes and minority youth,” she concluded.

The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Dabelea reported having no financial disclosures.

[email protected]

NEW ORLEANS – There is a high burden of early complications among young adults with type 1 or type 2 diabetes, results from an ongoing study demonstrated.

“We are witnessing a recent increase in type 2 diabetes in the pediatric U.S. population, paralleling a somewhat more established rise in type 1 diabetes among youth worldwide,” Dana Dabelea, MD, PhD, said at the annual scientific sessions of the American Diabetes Association. “In the face of this increasing disease burden, we are left with limited information on the consequences of having diabetes on these youth, specifically the burden of diabetes-related chronic complications. No study exists in the U.S. that is able to compare this burden in youth with type 2 versus those with type 1 diabetes. Prior studies elsewhere worldwide have used mostly medical records or administrative data, have small sample sizes, and include youth with variable disease duration.”

The aim of the current study was to assess and compare the prevalence of several complications in youth with either type 1 or type 2 diabetes of similar age and disease (short) duration, and to explore the potential risk factors for observed differences by diabetes type. Dr. Dabelea of the department of epidemiology at the University of Colorado School of Public Health in Denver, and her colleagues from the SEARCH for Diabetes in Youth Study, developed a cohort of 1,746 individuals with type 1 and 272 with type 2 diabetes, diagnosed when younger than age 20, assembled from the population-based SEARCH Registry in five U.S. sites, and registered upon diagnosis between 2002 and 2008. The most recent visit was between 2011 and 2015 when participants were at least 10 years of age.

Outcomes, measured once at the cohort visit between 2010 and 2015, included diabetic kidney disease, diabetic retinopathy, peripheral neuropathy, cardiovascular autonomic neuropathy, arterial stiffness, and hypertension.

Dr. Dabelea reported that 32% of youth with type 1 diabetes and 72% of those with type 2 diabetes had at least one early complication. For all complications, except cardiovascular autonomic neuropathy, the prevalence was significantly higher in those with type 2 diabetes, compared with those who had type 1 disease, with a similar pattern by race, especially for minority youth. Estimates were also usually higher within type among minority vs. non-white Hispanic youth, especially for type 2 diabetes. The findings “indicate a need for heightened clinical suspicion and detection of early complications, together with aggressive risk factor control, especially in type 2 diabetes and minority youth,” she concluded.

The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Dabelea reported having no financial disclosures.

[email protected]

NEW ORLEANS – An investigational hepatitis B vaccine known as Heplisav-B provided significantly better seroprotection among adults with type 2 diabetes than did a currently licensed vaccine, based on results from a randomized phase III trial.

A total of 321 patients received three doses of the Food and Drug Administration–approved vaccine Engerix-B at weeks 0, 4, and 24, while 640 patients received two doses of the investigational vaccine Heplisav-B at weeks 0 and 4 and a placebo injection at week 24. In both groups of patients, two-thirds of subjects had diabetes for 5 or more years, Randall N. Hyer, MD, reported in a poster at the annual scientific sessions of the American Diabetes Association.

Doug Brunk/Frontline Medical News

At 28 weeks, 90% of subjects in the Heplisav-B group and 65% in the Engerix-B group achieved seroprotection, defined as anti–hepatitis B titers of 10 mIU/mL or greater. The difference reached statistical significance. Among study participants aged 60-70 years, 85.8% of subjects in the Heplisav-B group achieved seroprotection, compared with 58.5% in the Engerix-B group. Among study participants with a body mass index of 30 kg/m², 89.5% of subjects in the Heplisav-B group achieved seroprotection, compared with 61.4% in the Engerix-B group, reported Dr. Hyer, who is vice president of medical affairs for Dynavax, the maker of Heplisav-B.

The safety profile, including the incidence of immune-mediated adverse events, was similar in both treatment groups. The most frequently reported local reaction was injection-site pain, while the most common systemic reactions were fatigue, headache, and malaise.

Dynavax submitted a biologics license application to the FDA in March 2016, and a decision on whether to approve Heplisav-B is expected by mid-December. “The Centers for Disease Control and Prevention does recommend that all adults with diabetes aged 19-59 be vaccinated against HBV [hepatitis B virus] as soon as feasible after diagnosis. For folks 60 and above, it’s at the discretion of the physician. People with type 2 diabetes are twice as likely to get HBV,” Dr. Hyer said in an interview.

Dynavax funded the study. Dr. Hyer is an employee of the company.

[email protected]

NEW ORLEANS – An investigational hepatitis B vaccine known as Heplisav-B provided significantly better seroprotection among adults with type 2 diabetes than did a currently licensed vaccine, based on results from a randomized phase III trial.

A total of 321 patients received three doses of the Food and Drug Administration–approved vaccine Engerix-B at weeks 0, 4, and 24, while 640 patients received two doses of the investigational vaccine Heplisav-B at weeks 0 and 4 and a placebo injection at week 24. In both groups of patients, two-thirds of subjects had diabetes for 5 or more years, Randall N. Hyer, MD, reported in a poster at the annual scientific sessions of the American Diabetes Association.

Doug Brunk/Frontline Medical News

At 28 weeks, 90% of subjects in the Heplisav-B group and 65% in the Engerix-B group achieved seroprotection, defined as anti–hepatitis B titers of 10 mIU/mL or greater. The difference reached statistical significance. Among study participants aged 60-70 years, 85.8% of subjects in the Heplisav-B group achieved seroprotection, compared with 58.5% in the Engerix-B group. Among study participants with a body mass index of 30 kg/m², 89.5% of subjects in the Heplisav-B group achieved seroprotection, compared with 61.4% in the Engerix-B group, reported Dr. Hyer, who is vice president of medical affairs for Dynavax, the maker of Heplisav-B.

The safety profile, including the incidence of immune-mediated adverse events, was similar in both treatment groups. The most frequently reported local reaction was injection-site pain, while the most common systemic reactions were fatigue, headache, and malaise.

Dynavax submitted a biologics license application to the FDA in March 2016, and a decision on whether to approve Heplisav-B is expected by mid-December. “The Centers for Disease Control and Prevention does recommend that all adults with diabetes aged 19-59 be vaccinated against HBV [hepatitis B virus] as soon as feasible after diagnosis. For folks 60 and above, it’s at the discretion of the physician. People with type 2 diabetes are twice as likely to get HBV,” Dr. Hyer said in an interview.

Dynavax funded the study. Dr. Hyer is an employee of the company.

[email protected]

NEW ORLEANS – An investigational hepatitis B vaccine known as Heplisav-B provided significantly better seroprotection among adults with type 2 diabetes than did a currently licensed vaccine, based on results from a randomized phase III trial.

A total of 321 patients received three doses of the Food and Drug Administration–approved vaccine Engerix-B at weeks 0, 4, and 24, while 640 patients received two doses of the investigational vaccine Heplisav-B at weeks 0 and 4 and a placebo injection at week 24. In both groups of patients, two-thirds of subjects had diabetes for 5 or more years, Randall N. Hyer, MD, reported in a poster at the annual scientific sessions of the American Diabetes Association.

Doug Brunk/Frontline Medical News

At 28 weeks, 90% of subjects in the Heplisav-B group and 65% in the Engerix-B group achieved seroprotection, defined as anti–hepatitis B titers of 10 mIU/mL or greater. The difference reached statistical significance. Among study participants aged 60-70 years, 85.8% of subjects in the Heplisav-B group achieved seroprotection, compared with 58.5% in the Engerix-B group. Among study participants with a body mass index of 30 kg/m², 89.5% of subjects in the Heplisav-B group achieved seroprotection, compared with 61.4% in the Engerix-B group, reported Dr. Hyer, who is vice president of medical affairs for Dynavax, the maker of Heplisav-B.

The safety profile, including the incidence of immune-mediated adverse events, was similar in both treatment groups. The most frequently reported local reaction was injection-site pain, while the most common systemic reactions were fatigue, headache, and malaise.

Dynavax submitted a biologics license application to the FDA in March 2016, and a decision on whether to approve Heplisav-B is expected by mid-December. “The Centers for Disease Control and Prevention does recommend that all adults with diabetes aged 19-59 be vaccinated against HBV [hepatitis B virus] as soon as feasible after diagnosis. For folks 60 and above, it’s at the discretion of the physician. People with type 2 diabetes are twice as likely to get HBV,” Dr. Hyer said in an interview.

Dynavax funded the study. Dr. Hyer is an employee of the company.

[email protected]

NEW ORLEANS – Premenopausal women with type 1 diabetes mellitus have a higher cardiovascular risk, compared with their diabetes-free counterparts. Among postmenopausal women, however, those with type 1 diabetes do not have a higher cardiovascular risk, compared with their peers who do not have diabetes, with the exception of those aged 54 and older.

Those are key findings from an analysis of women enrolled in the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study.

Doug Brunk/Frontline Medical News

“In general [premenopausal] women have a better cardiovascular profile than do men, but we don’t see that same effect in diabetic women,” lead author Amena Keshawarz said in an interview in advance of the annual scientific sessions of the American Diabetes Association. “They lose some of that protection. We’re wondering if that has some sort of relationship with menopause, because once women undergo menopause they tend to lose that protective factor.”

Ms. Keshawarz, a doctoral student and research assistant at the University of Colorado Barbara Davis Center for Childhood Diabetes, Aurora, and her associates used carotid intima-media thickness (cIMT) and the presence of coronary artery calcification to measure the cardiovascular risk by menopausal status in 106 women with type 1 diabetes and 140 nondiabetic women who were enrolled in CACTI. The patients ranged in age from 33-74 years and the data were collected between January 2014 and May 2016. Multivariable linear and logistic regressions were used to examine the differences in cIMT and to estimate the odds ratio for coronary artery calcification (CAC). The models were run for the following ages separately: 42, 42, 48, 51, 54, and 57 years.

As a group, women with type 1 diabetes were younger than their counterparts without diabetes (a mean age of 51 vs. 55 years, respectively; P = .002), but menopause age did not differ by diabetes status. Ms. Keshawarz reported that women with type 1 diabetes had significantly higher age-adjusted odds of significant CAC and higher cIMT, compared with those in the nondiabetic group, but these relationships differed by age and menopause status. For example, among premenopausal women, type 1 diabetes increased the odds of CAC at all ages, and cIMT was higher in women with type 1 diabetes, compared with those in the nondiabetic group at age 45 years and older. Among postmenopausal women, type 1 diabetes was associated with only higher CAC at age 54 years and older and with higher cIMT at age 57 years.

“Type 1 diabetic women face unique problems in their health that are not just endocrinology-related,” Ms. Keshawarz said. “If they haven’t undergone menopause yet, that needs to be taken into account when you’re proposing interventions and lifestyle and behavioral changes, because there is an increased possibility that they’re going to be at higher risk of coronary artery calcification and thicker [coronary] artery walls.”

The study was supported by grants from the American Diabetes Association and the National Institutes of Health. Ms. Keshawarz reported having no financial disclosures.

[email protected]

NEW ORLEANS – Premenopausal women with type 1 diabetes mellitus have a higher cardiovascular risk, compared with their diabetes-free counterparts. Among postmenopausal women, however, those with type 1 diabetes do not have a higher cardiovascular risk, compared with their peers who do not have diabetes, with the exception of those aged 54 and older.

Those are key findings from an analysis of women enrolled in the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study.

Doug Brunk/Frontline Medical News

“In general [premenopausal] women have a better cardiovascular profile than do men, but we don’t see that same effect in diabetic women,” lead author Amena Keshawarz said in an interview in advance of the annual scientific sessions of the American Diabetes Association. “They lose some of that protection. We’re wondering if that has some sort of relationship with menopause, because once women undergo menopause they tend to lose that protective factor.”

Ms. Keshawarz, a doctoral student and research assistant at the University of Colorado Barbara Davis Center for Childhood Diabetes, Aurora, and her associates used carotid intima-media thickness (cIMT) and the presence of coronary artery calcification to measure the cardiovascular risk by menopausal status in 106 women with type 1 diabetes and 140 nondiabetic women who were enrolled in CACTI. The patients ranged in age from 33-74 years and the data were collected between January 2014 and May 2016. Multivariable linear and logistic regressions were used to examine the differences in cIMT and to estimate the odds ratio for coronary artery calcification (CAC). The models were run for the following ages separately: 42, 42, 48, 51, 54, and 57 years.

As a group, women with type 1 diabetes were younger than their counterparts without diabetes (a mean age of 51 vs. 55 years, respectively; P = .002), but menopause age did not differ by diabetes status. Ms. Keshawarz reported that women with type 1 diabetes had significantly higher age-adjusted odds of significant CAC and higher cIMT, compared with those in the nondiabetic group, but these relationships differed by age and menopause status. For example, among premenopausal women, type 1 diabetes increased the odds of CAC at all ages, and cIMT was higher in women with type 1 diabetes, compared with those in the nondiabetic group at age 45 years and older. Among postmenopausal women, type 1 diabetes was associated with only higher CAC at age 54 years and older and with higher cIMT at age 57 years.

“Type 1 diabetic women face unique problems in their health that are not just endocrinology-related,” Ms. Keshawarz said. “If they haven’t undergone menopause yet, that needs to be taken into account when you’re proposing interventions and lifestyle and behavioral changes, because there is an increased possibility that they’re going to be at higher risk of coronary artery calcification and thicker [coronary] artery walls.”

The study was supported by grants from the American Diabetes Association and the National Institutes of Health. Ms. Keshawarz reported having no financial disclosures.

[email protected]

NEW ORLEANS – Premenopausal women with type 1 diabetes mellitus have a higher cardiovascular risk, compared with their diabetes-free counterparts. Among postmenopausal women, however, those with type 1 diabetes do not have a higher cardiovascular risk, compared with their peers who do not have diabetes, with the exception of those aged 54 and older.

Those are key findings from an analysis of women enrolled in the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study.

Doug Brunk/Frontline Medical News

“In general [premenopausal] women have a better cardiovascular profile than do men, but we don’t see that same effect in diabetic women,” lead author Amena Keshawarz said in an interview in advance of the annual scientific sessions of the American Diabetes Association. “They lose some of that protection. We’re wondering if that has some sort of relationship with menopause, because once women undergo menopause they tend to lose that protective factor.”

Ms. Keshawarz, a doctoral student and research assistant at the University of Colorado Barbara Davis Center for Childhood Diabetes, Aurora, and her associates used carotid intima-media thickness (cIMT) and the presence of coronary artery calcification to measure the cardiovascular risk by menopausal status in 106 women with type 1 diabetes and 140 nondiabetic women who were enrolled in CACTI. The patients ranged in age from 33-74 years and the data were collected between January 2014 and May 2016. Multivariable linear and logistic regressions were used to examine the differences in cIMT and to estimate the odds ratio for coronary artery calcification (CAC). The models were run for the following ages separately: 42, 42, 48, 51, 54, and 57 years.

As a group, women with type 1 diabetes were younger than their counterparts without diabetes (a mean age of 51 vs. 55 years, respectively; P = .002), but menopause age did not differ by diabetes status. Ms. Keshawarz reported that women with type 1 diabetes had significantly higher age-adjusted odds of significant CAC and higher cIMT, compared with those in the nondiabetic group, but these relationships differed by age and menopause status. For example, among premenopausal women, type 1 diabetes increased the odds of CAC at all ages, and cIMT was higher in women with type 1 diabetes, compared with those in the nondiabetic group at age 45 years and older. Among postmenopausal women, type 1 diabetes was associated with only higher CAC at age 54 years and older and with higher cIMT at age 57 years.

“Type 1 diabetic women face unique problems in their health that are not just endocrinology-related,” Ms. Keshawarz said. “If they haven’t undergone menopause yet, that needs to be taken into account when you’re proposing interventions and lifestyle and behavioral changes, because there is an increased possibility that they’re going to be at higher risk of coronary artery calcification and thicker [coronary] artery walls.”

The study was supported by grants from the American Diabetes Association and the National Institutes of Health. Ms. Keshawarz reported having no financial disclosures.

[email protected]