The Potential of Albiglutide, a Long-Acting GLP-1 Receptor Agonist, in Type 2 Diabetes: A Randomized Controlled Trial Exploring Weekly, Biweekly, and Monthly Dosing

Abstract

Objective — To evaluate the efficacy, safety, and tolerability of incremental doses of albiglutide, a long-acting GLP-1-receptor agonist, administered with 3 dosing schedules in patients with type 2 diabetes inadequately controlled with diet and exercise or metformin monotherapy.

Research design and methods — In this randomized, multicenter, double-blind, parallel-group study, 356 type 2 diabetic subjects with similar mean baseline characteristics (age 54 years, diabetes duration 4.9 years, BMI 32.1 kg/m², A1C 8.0%) received subcutaneous placebo or albiglutide [weekly (4, 15, or 30 mg); every two weeks, (biweekly; 15, 30, or 50 mg), or monthly (50 or 100 mg)] or exenatide twice daily as an open-label active reference (per labeling in metformin subjects only) over 16 weeks, followed by an 11-week washout period. Main outcome measure was change from baseline A1C of albiglutide groups versus placebo at week 16.

Results — Dose-dependent reductions in A1C were observed within all albiglutide schedules. Mean A1C was similarly reduced from baseline by albiglutide 30 mg weekly, 50 mg biweekly, and 100 mg monthly: −0.87%, −0.79%, and −0.87%, respectively, versus placebo, −0.17% (P < 0.004), and exenatide, −0.54%. Weight loss (−1.1 to −1.7 kg) was observed with these 3 albiglutide doses with no significant between-group effects. The incidence of gastrointestinal adverse events in subjects receiving albiglutide 30 mg weekly was less than observed for the highest biweekly and monthly doses of albiglutide or exenatide.

Conclusions — Weekly albiglutide administration significantly improved glycemic control and elicited weight loss in type 2 diabetes patients, with a favorable safety/tolerability profile.