Phase III and II Data for Pargluva Presented

Bristol-Myers Squibb and Merck & Co. have announced results from both a Phase III active-controlled study and a long-term Phase II dose-ranging study for the investigational oral medicine muraglitazar (now known under the registered trade name Pargluva) during a late-breaking presentation of the 65th Annual Scientific Sessions of the American Diabetes Association.

The primary endpoint of each study was reduction in A1C levels (a measure of a person's average blood glucose over a two- to three-month time period) in patients with Type 2 diabetes. Lipid effects, a secondary endpoint of both studies, were also measured.

The Phase III study showed Pargluva 5 mg reduced A1C levels significantly more than pioglitazone 30 mg in patients with Type 2 diabetes. Both treatment groups were taking metformin. Significant effects were also seen on triglycerides and high-density lipoprotein cholesterol (HDL-C) levels. In the Phase II study at 104 weeks, patients who received Pargluva 5 mg had a change of -1.52 percent from baseline A1C (mean baseline of 7.92 percent) with a final mean A1C level of 6.4 percent.

Bristol-Myers Squibb and Merck are collaborators in the global development and commercialization of Pargluva. The new drug application for Pargluva is currently under review by the FDA. If approved, Pargluva would become the first marketed agent in a new class of investigational compounds called glitazars. Pargluva is a dual alpha/gamma PPAR (peroxisome proliferator-activated receptor) activator.