Galvus (vildagliptin) is “not inferior to” Avandia (rosiglitazone) in Treating Type 2 Diabetes

A 24-week study compared the effectiveness and safety of Galvus (vildagliptin), a DPP-4 inhibitor, with Avandia (rosiglitazone), a thiazolidinedione, in a double-blind, randomized, controlled, multi-center study. Both drugs had similar effects on A1c’s: Galvus reduced A1c by 1.1 %, and Avandia reduced A1c by 1. 3%. Most notably, patients did not gain weight with Galvus, but gained an average of 3.4 pounds with Avandia.

Galvus, made by Novartis, is in the same class as sitagliptin (Januvia), another DPP-4 inhibitor. Unlike Januvia, Galvus has not been approved by the FDA. FDA approval was expected by November 2006, but then the FDA asked for more data about studies linking Galvus to skin lesions in monkeys. In late February 2007, the FDA asked for a clinical study in patients with kidney impairment. It now looks as if Galvus will not be approved by the FDA for a year or more.

Sources: Diabetes Care
Associated Press

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