The GLP-1 agonist albiglutide was added to the regimen of patients already on metformin and glimepiride…
An international team of researchers investigated the efficacy and tolerability of albiglutide, a weekly glucagon-like peptide-1 receptor (GLP-1) agonist, when added to metformin and glimepiride in a triple therapy regimen in people with type 2 diabetes mellitus.
This was a 156-week, randomized, double-blind, parallel-group, multicenter study. Adult participants (n = 685) were randomly assigned to albiglutide (30 mg/week), pioglitazone (30 mg/day) or placebo. If needed, blinded uptitration of albiglutide (to 50 mg/week) and pioglitazone (to 45 mg/day) was allowed. The participant’s current dose of metformin (>1500 mg/day) was maintained throughout. The glimepiride dose (4 mg/day), standardized before randomization, could be decreased if persistent hypoglycemia occurred.
The week 52 model-adjusted difference in change of glycated hemoglobin (primary endpoint) for albiglutide versus placebo was -0.87 [95% confidence interval (CI) -1.07, -0.68]%-units (p < 0.001), and for albiglutide versus pioglitazone it was 0.25 (95% CI 0.10, 0.40)%-units; therefore, not non-inferior. In the albiglutide group only, fasting plasma glucose reduced rapidly in the first 2 weeks. Confirmed hypoglycemia occurred in 14% of participants on albiglutide, 25% on pioglitazone and 14% on placebo. The mean (± standard error) weight change was -0.42 (±0.2) kg with albiglutide, +4.4 (±0.2) kg (p < 0.001) with pioglitazone, and -0.40 (±0.4) kg with placebo and serious adverse events occurred in 6.3, 9.0 and 6.1% of participants in the respective groups. Injection site reactions occurred in 13% of participants on albiglutide and resulted in treatment discontinuation for four participants (1.4%).
The researchers concluded that albiglutide as part of triple therapy provided effective glucose-lowering and was generally well-tolerated.
- In this double-blind, randomized study, researchers followed 685 adults taking metformin and glimepiride at baseline. Albiglutide, pioglitazone, or placebo was added to their regimen. After 1 year, the model-adjusted difference in HbA1c for albiglutide vs placebo was −0.87 (P < .001). In the albiglutide group only, fasting plasma glucose reduced rapidly in the first 2 weeks. Confirmed hypoglycemia occurred in 14% with albiglutide, 25% with pioglitazone, and 14% with placebo.
- As a part of triple therapy, albiglutide was effective and well-tolerated.
Efficacy and Tolerability of Albiglutide Versus Placebo or Pioglitazone Over 1 Year in People With Type 2 Diabetes Currently Taking Metformin and Glimepiride: HARMONY 5 Diabetes Obes Metab 2014 Dec 10;[EPub Ahead of Print], PD Home