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Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone

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ClinicalTrials.gov Identifier: NCT00095030
Recruitment Status : Completed
First Posted : November 1, 2004
Last Update Posted : September 14, 2010
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: muraglitazar Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1752 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Three-Arm, Double-blind, Active Controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Subjects Wtih Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Study Start Date : February 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Glimepiride




Primary Outcome Measures :
  1. Change in baseline HbA1c after 52 weeks

Secondary Outcome Measures :
  1. Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks


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:

  • Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening
  • HbA1c >or = 7% and < or = 10%
  • Fasting c-peptide > or = 1.0 umol
  • Body Mass Index < or = 41 kg/m2
  • Mean serum triglycerides < or = 600 mg/dl

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): NCT00095030


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Sponsors and Collaborators
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00095030     History of Changes
Other Study ID Numbers: CV168-048
First Posted: November 1, 2004    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2007

Keywords provided by Bristol-Myers Squibb:
Diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Glimepiride
Glycine
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action