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Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone

MULTI-CENTER STUDY IN PHASE III, RANDOMIZED, OF THREE BRANCHES, DOUBLE-BLIND CONTROLLED WITH A PARALLEL ACTIVE GROUP TO EVALUATE THE SAFETY AND EFFICACY OF MURAGLITAZAR COMBINED WITH METFORMIN COMPARED WITH GLIMEPIRIDE COMBINED WITH METFORMIN IN PATIENTS WITH DIABETES TYPE 2 THAT HAVE INAPPROPRIATE CONTROL OF THE GLUCEMIA TO BE TREATED WITH METFORMIN AS MONOTHERAPY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-055-04
Enrollment
72
Registered
2004-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

muraglitazar 2.5 mg plus metformin Type of group
Muraglitazar 2.5 mg plus metformin is administered openly for 104 weeks. Group name:Glimepiride 1mg plus metformin Type of group
Glimepiride 1mg plus metformin are administered in open form for 104 weeks.

Sponsors

BRISTOL MYERS SQUIBB COMPANY,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening HbA1c >or = 7% and or = 1.0 umol Body Mass Index < or = 41 kg/m2 Mean serum triglycerides < or = 600 mg/dl

Exclusion criteria

Exclusion criteria: 1. History of diabetic ketoacidosis, hyperosmolar non-ketotic coma or insulin treatment within one year of selection. 2. Symptomatic type 2 diabetes, defined by polyuria and polydipsia with weight loss greater than 10% during the last three months. 3. History of myocardial infarction (MI), coronary angioplasty, or bypass graft (s), valvular disease or repair, unstable angina, TIA, or cerebrovascular accidents, within six months prior to entering the study.

Design outcomes

Primary

MeasureTime frame
Outcome name:Change in HbA1c from baseline to week 32 Measure:Change in HbA1c from baseline to week 32 Timepoints:week 32—

Secondary

MeasureTime frame
Outcome name:HDL, TG, C not HDL, and apoB Measure:Percent change in fasting lipid levels from baseline to Week 12 Timepoints:week 12—

Countries

Argentina, Australia, Brazil, Canada, Chile, China, Germany, Mexico, Philippines, Poland, Russian Federation, Switzerland, Taiwan, Thailand

Outcome results

None listed

Source: REPEC (via WHO ICTRP)