Chicago—After 104 weeks of treatment, patients with type 2 diabetes who received albiglutide in combination with metformin had statistically and clinically significant glucose reductions compared with patients who took sitagliptin, glimepiride, or placebo, according to a phase 3, randomized, double-blind study.
Results were presented during a late-breaking poster session at the ADA meeting. The poster was titled HARMONY 3: 104-Week Efficacy of Albiglutide Compared to Sitagliptin and Glimepiride in Patients with Type 2 Diabetes Mellitus (T2DM) on Metformin.
Albiglutide is an investigational glucagon-like peptide-1 (GLP-1) agonist injected subcutaneously once weekly in patients with type 2 diabetes. GlaxoSmithKline announced in January 2013 that it had filed a regulatory submission to the FDA for albiglutide. Sitagliptin is an FDA-approved dipeptidyl peptidase-4 inhibitor taken once daily with or without food. Glimepiride is an FDA-approved sulfonylurea taken once daily.
In this study, the authors enrolled 1012 patients with type 2 diabetes who were ≥18 years of age, had inadequate glycemic control on metformin monotherapy, and had a baseline hemoglobin A1c (HbA1c) level from 7.0% to 10.0%.
Patients were randomized in a 3:3:3:1 ratio to receive 30 mg to 50 mg of albiglutide once weekly (n=302), 100 mg of sitagliptin once daily (n=302), 2 mg to 4 mg of glimepiride once daily (n=307), or a placebo injection once weekly (n=101).
At baseline, the groups were well balanced. Approximately 50% of patients were male, mean age was approximately 55 years, mean body mass index was 32.5 kg/m2, and mean HbA1c was approximately 8.0%.
After 104 weeks of treatment, patients in the albiglutide group had a 0.9% mean reduction in HbA1c compared with placebo (P<.0001), a 0.4% mean reduction compared with sitagliptin (P=.0001), and a 0.3% mean reduction compared with glimepiride (P=.003). In addition, patients in the albiglutide group lost a mean of 2.4 kg more compared with the glimepiride group (P<.0001), but the differences between albiglutide and sitagliptin and placebo were not statistically significant.
At week 104, 58.7% of patients in the albiglutide group had an HbA1c <7.5% compared with 49.2% of patients in the glimepiride group (P<.05), 44.4% in the sitagliptin group (P<.05), and 27.8% in the placebo group (P<.05). More patients in the albiglutide group also had an HbA1c <7.0% and <6.5% compared with the glimepiride and sitagliptin groups, but the differences were not statistically significant.
Adverse events were found in 79% of patients in the placebo group, 79% in the sitagliptin group, 83% in the glimepiride group, and 84% in the albiglutide group. Serious adverse events were found in 13%, 8%, 9%, and 11% of patients in the groups, respectively, while treatment-related adverse events were found in 21%, 18%, 18%, and 31% of patients in the groups, respectively.
The most common adverse events in patients taking albiglutide were upper respiratory tract infection (16.2%), diarrhea (12.6%), nausea (10.3%), injection site reaction (9.6%), hypertension (7.9%), nasopharyngitis (7.6%), and cough (7.3%). The authors noted that the adverse events associated with albiglutide were consistent with other GLP-1 agonists.
GlaxoSmithKline funded this study.