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Diabetes and Vascular Disease Research
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Efficacy and safety of muraglitazar: a double-blind, 24-week, dose-ranging study in patients with type 2 diabetes

Cindy J. Rubin

Pharmaceutical Research Institute, Bristol-Myers Squibb, Princeton, New Jersey, USA, cindy.rubin{at}bms.com

Kalyanee Viraswami-Appanna

Pharmaceutical Research Institute, Bristol-Myers Squibb, Princeton, New Jersey, USA, Biostatistics and Statistical Reporting, Novartis Pharmaceutical Corporation, USA

Fred T. Fiedorek

Pharmaceutical Research Institute, Bristol-Myers Squibb, Princeton, New Jersey, USA

Muraglitazar is a dual ({alpha}/{gamma}) PPAR activator. Dual receptor activation may improve glycaemic and lipid profiles in patients with type 2 diabetes mellitus.This randomised double-blind trial in 1,477 drug-naive patients with type 2 diabetes compared the efficacy and safety of muraglitazar (0.5, 1.5, 5, 10, and 20 mg) with pioglitazone (15 mg). Endpoints included changes in HbA1C and plasma lipids, last observation carried forward over 24 weeks. At week 24, mean changes from baseline in HbA1C ranged from —0.25% to —1.76% with muraglitazar (p≤0.0008, 0.5 mg versus each higher muraglitazar dose), compared with —0.57% with pioglitazone. At week 12, tri-glycerides decreased 4—41% with muraglitazar and 9% with pioglitazone. High-density lipoprotein cholesterol increased 6—23% with muraglitazar and 10% with pioglitazone. Oedema-related events occurred with muraglitazar in a dose-dependent incidence (range 9—40%), and at 14% with pioglitazone. Overall, muraglitazar produced simultaneous dose-dependent improvements in glycaemic and lipid parameters in drug-naive patients with type 2 diabetes mellitus.

Key Words: PPAR {alpha}/{gamma} activator • PPAR agonist • type 2 diabetes • oral antidiabetic therapy

Diabetes and Vascular Disease Research, Vol. 6, No. 3, 205-215 (2009)
DOI: 10.1177/1479164109336048
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