Albiglutide Superior to Sitagliptin in Improving Glycemic Control

Chicago-After 26 weeks of treatment, patients with type 2 diabetes and renal impairment who took fixed-dose albiglutide once per week had better glycemic control and a reduction in body weight compared with a group receiving adjustable-dose sitagliptin, according to a phase 3, randomized, double-blind, active-controlled, parallel-group trial.

Lawrence A. Leiter, MD, the study’s lead author, presented the results on Saturday at the ADA meeting in an oral abstract session.

In January, GlaxoSmithKline submitted a new drug application to the FDA for albiglutide’s approval. The drug, a long-acting glucagon-like peptide-1 receptor agonist, is not approved in any country for type 2 diabetes. The FDA has approved sitagliptin as a monotherapy and in combination with metformin or simvastatin.

Patients in this study had hemoglobin A1c (HbA1c) levels between 7% and 10% and inadequate glycemic control after taking oral antidiabetic medications or undergoing a diet and exercise regimen. The mean age was approximately 63 years of age, and approximately 53% of patients were males and 45% were white. The mean HbA1c level at baseline was 8.1%.

After a 4-week, run-in period, they were randomized in a 1:1 ratio to receive 30 mg of albiglutide or 25, 50, or 100 mg of sitagliptin. At week 26, the mean HbA1c level had decreased by 0.8% for patients in the albiglutide group compared with a 0.5% reduction in the sitagliptin group (P=.0003). In addition, fasting plasma glucose levels decreased from baseline by a mean of 26 mg/dL in the albiglutide group compared with a mean reduction of 4 mg/dL in the sitagliptin group (P<.0001).

Further, the mean weight reduction after 26 weeks was 0.8 kg for the albiglutide group and 0.2 kg in the sitagliptin patients (P=.0281). Patients taking sitagliptin also had more adverse events, serious adverse events, and adverse events leading to withdrawal. The most common adverse events included diarrhea, and constipation, and none were found in more than 10% of patients.

-Tim Casey