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Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00106808
First Posted: April 1, 2005
Last Update Posted: September 14, 2010
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
Type 2 Diabetes Mellitus Drug: Muraglitazar Drug: Pioglitazone Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

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

Estimated Enrollment: 1440
Study Start Date: August 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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): NCT00106808


  Show 197 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00106808     History of Changes
Other Study ID Numbers: CV168-062
First Submitted: March 31, 2005
First Posted: April 1, 2005
Last Update Posted: September 14, 2010
Last Verified: September 2007

Keywords provided by Bristol-Myers Squibb:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Glycine
Hypoglycemic Agents
Physiological Effects of Drugs
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action