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Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

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. Identifier: NCT00106808
Recruitment Status : Completed
First Posted : April 1, 2005
Last Update Posted : September 14, 2010
Merck Sharp & Dohme Corp.
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1440 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 Muraglitazar (BMS-298585) Compared to Pioglitazone in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study Start Date : August 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in HBA1c from baseline to Week 24

Secondary Outcome Measures :
  1. Change for baseline in TG and HDL-C at Week 24
  2. Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
  3. To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  • Type 2 Diabetes
  • HbA1c > = 8.0% and < = 12.0%
  • Serum triglyceride concentration < = 600 mg/dL
  • Fasting c-peptide > = 1.0 ng/ml
  • Body mass index < = 41 kg/m2
  • Drug naive patients

Exclusion Criteria:

  • History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase.
  • Women of child Bearing Potential
  • Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase.
  • History of renal disease, bladder cancer, 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 identifier (NCT number): NCT00106808

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Sponsors and Collaborators
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Layout table for additonal information Identifier: NCT00106808    
Other Study ID Numbers: CV168-062
First Posted: April 1, 2005    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2007
Keywords provided by Bristol-Myers Squibb:
Type 2 Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs