Albiglutide Approved as Once Weekly Treatment for Type 2 Diabetes
The U.S. Food and Drug Administration has approved a third glucagon-like peptide-1 (GLP-1) receptor antagonist—albiglutide—for use as an adjunct to diet and exercise in the treatment of type 2 diabetes. The agent is given subcutaneously by injection and is not approved as a first-line therapy in patients inadequately controlled with diet and exercise alone.
Approval was based on eight phase III trials, known as the Harmony program, involving more than 5,000 patients. The first two trials were placebo controlled and showed significant reductions in hemoglobin A1c levels with albiglutide versus placebo when given in combination with pioglitazone (Harmony 1), and with albiglutide versus placebo in combination with diet and exercise in treatment-naïve patients (Harmony 2).
The remaining six studies were active-controlled and compared albiglutide against other type 2 diabetes treatments (eg, insulin, glimepiride, metformin, pioglitazone, and sitagliptin) in patients at different stages of the disease, as well as in patients with renal impairment. In 5 of the 6 studies, albiglutide was associated with a greater or similar reduction in A1c than the comparison group.
In Harmony 7, both albiglutide and the GLP-1 agonist liraglutide were associated with clinically meaningful reductions in A1c levels at 32 weeks (-0.78% and -0.99%, respectively); however, albiglutide did not meet a prespecified non-inferiority margin compared to liraglutide. Weight loss was significantly greater in patients given liraglutide than in those given albiglutide (-2.19 kg vs -0.64 kg; P<0.0001). Albiglutide was associated with significantly less nausea (P<0.0001) and vomiting (P=0.0154) than liraglutide.
“The results of the Harmony 7 trial demonstrated that the once-weekly GLP-1 receptor agonist albiglutide effectively lowered A1c and was well tolerated with a low incidence of nausea," said lead author Richard E. Pratley, MD, Director of the Florida Hospital Diabetes Institute, Senior Scientist at Translational Research Institute for Metabolism and Diabetes, and Professor at Sanford-Burnham Medical Research Institute, Orlando, Florida.