Status:
COMPLETED
A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combinati...
Eligibility Criteria
Inclusion
- Type 2 diabetics
- HbA1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study.
- Fasting C-peptide ≥1.0 ng/mL
- BMI≤41 kg/m2 mean fasting serum trig. ≤600 g/dL
Exclusion
- symptomatic type 2 diabetics with \> 10% weight loss 3 months prior to study
- history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling
- History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history of, or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
1159 Patients enrolled
Trial Details
Trial ID
NCT00240370
Start Date
October 1 2003
Last Update
September 14 2010
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Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Mesa, Arizona, United States
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Peoria, Arizona, United States