Improvement of glycaemic and lipid profiles with muraglitazar plus metformin in patients with type 2 diabetes: an active-control trial with glimepiride.
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.
Rubin
Cindy J
CJ
Pharmaceutical Research Institute, Bristol-Myers Squibb, Princeton, New Jersey 08543, USA. cindy.rubin@bms.com
Ledeine
Jean-Marie
JM
Fiedorek
Fred T
FT
D000284:Administration, Oral; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D005998:Glycine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010080:Oxazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D005998:Glycine; D007004:Hypoglycemic Agents; D000960:Hypolipidemic Agents; D008055:Lipids; D008687:Metformin; D010080:Oxazoles; D013453:Sulfonylurea Compounds; C517652:hemoglobin A1c protein, human; C057619:glimepiride; C500085:muraglitazar