A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics

Condition(s) targeted: Type 2 Diabetes

Intervention: Muraglitazar (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

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 combination of muraglitazar and metformin compared to pioglitazone and metformin.

Official title: A Phase 3, Randomized, Double-Blind, Active-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Compared to Pioglitazone in Combination With Metformin in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin

Secondary outcome:

Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in

hs-CRP from baseline to W24

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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.

Local Institution, Aguascalientes, Mexico

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BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: October 2003
Last updated: September 27, 2007