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Albiglutide Shows Promise in Phase III Diabetes Trials

Drug would face stiff competition if approved (June 24)

Positive data from several long-term phase III studies comparing albiglutide, an investigational glucagon-like peptide (GLP-1) receptor agonist, with placebo and a range of active comparators were presented at the American Diabetes Association meeting, held June 21–25 in Chicago, Illinois. The active comparators in the studies were insulin, a sulphonylurea, a thiazolidinedione, and a dipeptidyl peptidase 4 inhibitor (DPP-4).

In the Harmony 1 trial, a 3-year, 52-week primary end point, randomized, double-blind, placebo-controlled study, patients inadequately controlled on a current regimen of pioglitazone with or without metformin were treated with either albiglutide (30 mg) or placebo. At the 52-week primary end point, albiglutide combination therapy demonstrated a statistically significant reduction in hemoglobin A1c (HbA1c) from baseline compared with placebo (treatment difference of –0.8%; P < 0.0001). Forty-four percent of the albiglutide-treated patients achieved an HbA1c target of less than 7% compared with 15% for those receiving placebo.

Harmony 2, a 3-year, 52-week primary end point, randomized, double-blind, placebo-controlled study, compared albiglutide (30 mg or 50 mg) with placebo in drug-naïve diabetic patients on diet and exercise. At 52 weeks, both albiglutide doses demonstrated statistically significant HbA1c reductions compared with placebo (30-mg dose: –0.84%; 50-mg dose: –1.0%; both P < 0.0001).

Harmony 3 was a 3-year, 104-week primary end point, randomized, double-blind, placebo- and active-controlled, parallel-group study comparing the efficacy and safety of albiglutide, sitagliptin, glimepiride, and placebo in diabetic patients taking and inadequately controlled on metformin. At week 104, the reduction in HbA1c was statistically significant in the albiglutide group compared with those treated with placebo (–0.9%; P < 0.0001), sitagliptin (–0.4%; P = 0.0001), or glimepiride (–0.3%; P = 0.003).

In Harmony 4, a 3-year, 52-week primary end point, randomized, open-label study, albiglutide was compared with insulin glargine in subjects receiving metformin with or without a sulphonylurea. Both groups achieved a similar reduction in HbA1c (–0.7% and –0.8%, respectively). The treatment difference of 0.11% indicated the non-inferiority of albiglutide versus insulin glargine.

Harmony 5 was a 3-year, 52-week primary end point, randomized, double-blind study that evaluated the efficacy and safety of albiglutide compared with placebo and pioglitazone in patients on a background therapy of metformin and glimerpiride. At week 52, the reduction in HbA1c in the albiglutide group was statistically significant versus the placebo group (–0.9%; P < 0.001). Non-inferiority was not achieved versus the pioglitazone group (0.3%; P = 0.27).

According to Reuters, albiglutide would face stiff competition if approved. It belongs to the same class of injectable GLP-1 drugs as liraglutide (Victoza, Novo Nordisk), exenatide (Byetta, Amlyn Pharmaceuticals), and extended-release exenatide (Bydureon, Bristol-Myers Squibb/AstraZeneca).

Sources: GlaxoSmithKline; June 24, 2013; and Reuters; June 24, 2013.

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