Abstract
The efficacy and safety of muraglitazar versus glimepiride were evaluated in patients with type 2 diabetes. After open-label metformin monotherapy, 1,805 patients received randomised therapy with muraglitazar 2.5 mg or 5 mg or with glimepiride 1 mg in a double-blind 52-week study. The primary end point was change in glycosylated haemoglobin (HbA1C); secondary end points were changes in fasting lipid levels and glycaemic indices. At week 52, the reduction in HbA1C with muraglitazar 5 mg plus metformin was superior (p<0.0001) and with muraglitazar 2.5 mg it was non-inferior in comparison with glimepiride. At week 12, muraglitazar significantly decreased triglyceride levels (p<0.0001) and increased levels of high-density lipoprotein cholesterol (HDL-C) (p<0.0001). Oedema, weight gain and heart failure were more evident with muraglitazar. Muraglitazar 5 mg plus metformin significantly improved HbA1C, triglyceride and HDL-C levels in patients with type 2 diabetes. Cardiovascular events were similar among groups (~2%), but there was an imbalance of total mortality in favour of glimepiride.
Trial registration:
ClinicalTrials.gov NCT00095030.
Publication types
-
Clinical Trial, Phase III
-
Comparative Study
-
Multicenter Study
-
Randomized Controlled Trial
-
Research Support, Non-U.S. Gov't
MeSH terms
-
Administration, Oral
-
Aged
-
Blood Glucose / drug effects*
-
Diabetes Mellitus, Type 2 / drug therapy*
-
Diabetes Mellitus, Type 2 / metabolism
-
Diabetes Mellitus, Type 2 / mortality
-
Double-Blind Method
-
Drug Therapy, Combination
-
Female
-
Glycated Hemoglobin / metabolism
-
Glycine / administration & dosage
-
Glycine / adverse effects
-
Glycine / analogs & derivatives*
-
Glycine / therapeutic use
-
Humans
-
Hypoglycemic Agents / adverse effects
-
Hypoglycemic Agents / therapeutic use*
-
Hypolipidemic Agents / administration & dosage
-
Hypolipidemic Agents / adverse effects
-
Hypolipidemic Agents / therapeutic use*
-
Lipids / blood*
-
Male
-
Metformin / administration & dosage
-
Metformin / adverse effects
-
Metformin / therapeutic use*
-
Middle Aged
-
Oxazoles / administration & dosage
-
Oxazoles / adverse effects
-
Oxazoles / therapeutic use*
-
Sulfonylurea Compounds / administration & dosage
-
Sulfonylurea Compounds / adverse effects
-
Sulfonylurea Compounds / therapeutic use*
-
Time Factors
-
Treatment Outcome
Substances
-
Blood Glucose
-
Glycated Hemoglobin A
-
Hypoglycemic Agents
-
Hypolipidemic Agents
-
Lipids
-
Oxazoles
-
Sulfonylurea Compounds
-
hemoglobin A1c protein, human
-
glimepiride
-
Metformin
-
Glycine
-
muraglitazar
Associated data
-
ClinicalTrials.gov/NCT00095030