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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240370
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

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 combination of muraglitazar and metformin compared to pioglitazone and metformin.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Muraglitazar Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : October 2003
Actual Primary Completion Date : March 2005

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. 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
  2. hs-CRP from baseline to W24


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240370


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb

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ClinicalTrials.gov Identifier: NCT00240370    
Other Study ID Numbers: CV168-025
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: June 2008
Additional relevant MeSH terms:
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Metformin
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs