Comparator clinical trials of surrogate endpoints with albiglutide are in HARMONY

Abstract

Evaluation of: Ahrén B, Johnson SL, Stewart M et al. HARMONY 3: 104-Week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 3 diabetes taking metformin. Diabetes Care 2014;37:2141-8 and Rosenstock J, Fonseca VA, Grass JL et al. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care 2014;37:2317-25. Agonists of glucagon-like peptide-1 (GLP-1) receptors are used in the treatment of Type 2 diabetes. Albiglutide is a new long-acting GLP-1 receptor agonist being developed for once weekly use. This is an evaluation of two clinical trials in the HARMONY clinical trials series. HARMONY 3 compares albiglutide with sitagliptin and glimepiride in subjects with Type 2 diabetes poorly controlled with metformin, and HARMONY 6 compares albiglutide with insulin lispro in subjects poorly controlled with slow/medium release preparations of insulin. Both studies showed that albiglutide lowered HbA1c and had advantages over its comparator drugs. However, questions remain about the safety of albiglutide. Albiglutide is not being used in subjects with a history of thyroid cancer because it is not known whether this is a rare adverse effect with albiglutide. Also, the safety of albiglutide in subjects with Type 2 diabetes and high cardiovascular risk is unknown.

Keywords: GLP-1 receptor agonists; HbA1c; Type 2 diabetes; albiglutide; cardiovascular safety; thyroid cancer.