In this trial we evaluated the efficacy and safety of muraglitazar, a dual (alpha/gamma) peroxisome proliferator-activated receptor activator, plus glyburide in patients with type 2 diabetes not controlled with sulphonylurea monotherapy. After 2 weeks of open-label glyburide (15 mg/day), 583 patients were randomised to additionally receive muraglitazar 2.5 mg, 5 mg, or placebo. End points included changes in HbA(1C) and fasting plasma glucose (FPG) at weeks 24 and 102, and changes in lipid parameters at weeks 11/12 and 102.At week 24, mean changes from baseline in HbA(1C) and FPG were significantly greater with glyburide plus muraglitazar 2.5 mg or 5 mg than with glyburide plus placebo (p<0.0001). At week 11/12, triglyceride levels were significantly reduced with muraglitazar (p<0.0001). During the extension phase, muraglitazar demonstrated long-term glycaemic and lipid effects through week 102. Although generally well tolerated, muraglitazar was associated with higher rates of congestive heart failure, cardiovascular events, weight gain and oedema.
Trial registration: ClinicalTrials.gov NCT00162175.