Newcomer misses noninferiority mark against established GLP-1 receptor agonist

Once-daily liraglutide slightly outperformed once-weekly albiglutide in a head-to-head trial in adults with poorly controlled type 2 diabetes, researchers reported in the April issue of the Lancet Diabetes & Endocrinology.

Both glucagon-like peptide-1 (GLP-1) receptor agonists led to clinically meaningful reductions in hemoglobin A_1c levels, but the investigational agent albiglutide did not meet its prespecified noninferiority margin, compared with liraglutide, said Dr. Richard Pratley of the Florida Hospital Diabetes and Translational Research Institute and the Sanford-Burnham Medical Research Institute in Orlando and his associates.

The investigators conducted the phase III, open-label HARMONY 7 study in eight countries (Lancet Diabetes Endocrinol. 2014;2:289-97). They randomized 812 adults who had inadequately controlled type 2 diabetes and a body mass index between 20 and 45 kg/m² to receive either 30 mg albiglutide once weekly titrated to 50 mg at week 6, or 0.6 mg liraglutide once daily titrated to 1.2 mg at week 1 and to 1.8 mg at week 2.

At week 32, the liraglutide group had a 0.99% decrease in HbA_1c levels, compared with a 0.78% decrease for the albiglutide group (noninferiority, P = .085), the researchers reported.

Liraglutide also was associated with significantly fewer injection-site reactions than albiglutide (5.4% vs. 12.9% for albiglutide), but with a significantly higher frequency of nausea and vomiting (49.0% vs. 35.9%).

Based on the findings, "albiglutide could be a suitable alternative to liraglutide for some patients with type 2 diabetes who are candidates for GLP-1 receptor agonist treatment," the researchers wrote. "Consistent with the recent position statement of the American Diabetes Association and the European Association for the Study of Diabetes, the entire clinical picture should be considered so that treatment can be personalized based not only on HbA_1c reduction reported in many trials, but also on tolerability, safety, and frequency and ease of administration."

Albiglutide was granted marketing authorization by the European Commission in March, according to a statement from GlaxoSmithKline, which funded the study. It is under review at the Food and Drug Administration, with a response expected by April 15, the company said.

GlaxoSmithKline funded the study. Five coauthors reported financial relationships with GSK or other GLP-1 receptor manufacturers. Four other coauthors are GSK employees and shareholders.

Once-daily liraglutide slightly outperformed once-weekly albiglutide in a head-to-head trial in adults with poorly controlled type 2 diabetes, researchers reported in the April issue of the Lancet Diabetes & Endocrinology.

Both glucagon-like peptide-1 (GLP-1) receptor agonists led to clinically meaningful reductions in hemoglobin A_1c levels, but the investigational agent albiglutide did not meet its prespecified noninferiority margin, compared with liraglutide, said Dr. Richard Pratley of the Florida Hospital Diabetes and Translational Research Institute and the Sanford-Burnham Medical Research Institute in Orlando and his associates.

The investigators conducted the phase III, open-label HARMONY 7 study in eight countries (Lancet Diabetes Endocrinol. 2014;2:289-97). They randomized 812 adults who had inadequately controlled type 2 diabetes and a body mass index between 20 and 45 kg/m² to receive either 30 mg albiglutide once weekly titrated to 50 mg at week 6, or 0.6 mg liraglutide once daily titrated to 1.2 mg at week 1 and to 1.8 mg at week 2.

At week 32, the liraglutide group had a 0.99% decrease in HbA_1c levels, compared with a 0.78% decrease for the albiglutide group (noninferiority, P = .085), the researchers reported.

Liraglutide also was associated with significantly fewer injection-site reactions than albiglutide (5.4% vs. 12.9% for albiglutide), but with a significantly higher frequency of nausea and vomiting (49.0% vs. 35.9%).

Based on the findings, "albiglutide could be a suitable alternative to liraglutide for some patients with type 2 diabetes who are candidates for GLP-1 receptor agonist treatment," the researchers wrote. "Consistent with the recent position statement of the American Diabetes Association and the European Association for the Study of Diabetes, the entire clinical picture should be considered so that treatment can be personalized based not only on HbA_1c reduction reported in many trials, but also on tolerability, safety, and frequency and ease of administration."

Albiglutide was granted marketing authorization by the European Commission in March, according to a statement from GlaxoSmithKline, which funded the study. It is under review at the Food and Drug Administration, with a response expected by April 15, the company said.

GlaxoSmithKline funded the study. Five coauthors reported financial relationships with GSK or other GLP-1 receptor manufacturers. Four other coauthors are GSK employees and shareholders.

Once-daily liraglutide slightly outperformed once-weekly albiglutide in a head-to-head trial in adults with poorly controlled type 2 diabetes, researchers reported in the April issue of the Lancet Diabetes & Endocrinology.

Both glucagon-like peptide-1 (GLP-1) receptor agonists led to clinically meaningful reductions in hemoglobin A_1c levels, but the investigational agent albiglutide did not meet its prespecified noninferiority margin, compared with liraglutide, said Dr. Richard Pratley of the Florida Hospital Diabetes and Translational Research Institute and the Sanford-Burnham Medical Research Institute in Orlando and his associates.

The investigators conducted the phase III, open-label HARMONY 7 study in eight countries (Lancet Diabetes Endocrinol. 2014;2:289-97). They randomized 812 adults who had inadequately controlled type 2 diabetes and a body mass index between 20 and 45 kg/m² to receive either 30 mg albiglutide once weekly titrated to 50 mg at week 6, or 0.6 mg liraglutide once daily titrated to 1.2 mg at week 1 and to 1.8 mg at week 2.

At week 32, the liraglutide group had a 0.99% decrease in HbA_1c levels, compared with a 0.78% decrease for the albiglutide group (noninferiority, P = .085), the researchers reported.

Liraglutide also was associated with significantly fewer injection-site reactions than albiglutide (5.4% vs. 12.9% for albiglutide), but with a significantly higher frequency of nausea and vomiting (49.0% vs. 35.9%).

Based on the findings, "albiglutide could be a suitable alternative to liraglutide for some patients with type 2 diabetes who are candidates for GLP-1 receptor agonist treatment," the researchers wrote. "Consistent with the recent position statement of the American Diabetes Association and the European Association for the Study of Diabetes, the entire clinical picture should be considered so that treatment can be personalized based not only on HbA_1c reduction reported in many trials, but also on tolerability, safety, and frequency and ease of administration."

Albiglutide was granted marketing authorization by the European Commission in March, according to a statement from GlaxoSmithKline, which funded the study. It is under review at the Food and Drug Administration, with a response expected by April 15, the company said.

GlaxoSmithKline funded the study. Five coauthors reported financial relationships with GSK or other GLP-1 receptor manufacturers. Four other coauthors are GSK employees and shareholders.