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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
muraglitazar
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

Change in baseline HbA1c after 52 weeks

Secondary Outcome Measures

Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks

Full Information

First Posted
October 29, 2004
Last Updated
September 10, 2010
Sponsor
Bristol-Myers Squibb
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00095030
Brief Title
Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone
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 Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1752 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
muraglitazar
Primary Outcome Measure Information:
Title
Change in baseline HbA1c after 52 weeks
Secondary Outcome Measure Information:
Title
Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
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Germany
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Manila
Country
Philippines
Facility Name
Local Institution
City
Pasig City
Country
Philippines
Facility Name
Local Institution
City
Quezon
Country
Philippines
Facility Name
Local Institution
City
Gorzow Wielkopolski
Country
Poland
Facility Name
Local Institution
City
Krakow
Country
Poland
Facility Name
Local Institution
City
Mrokow
Country
Poland
Facility Name
Local Institution
City
Stalowa Wola
Country
Poland
Facility Name
Local Institution
City
Warszawa
Country
Poland
Facility Name
Local Institution
City
Wroclaw
Country
Poland
Facility Name
Local Institution
City
Zabrze
Country
Poland
Facility Name
Local Institution
City
Carolina
Country
Puerto Rico
Facility Name
Local Institution
City
Ponce
Country
Puerto Rico
Facility Name
Local Institution
City
Rio Piedras
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
Country
Puerto Rico
Facility Name
Local Institution
City
Moscow
Country
Russian Federation
Facility Name
Local Institution
City
Smolensk
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
Country
Russian Federation
Facility Name
Local Institution
City
Baden
Country
Switzerland
Facility Name
Local Institution
City
Changhua
Country
Taiwan
Facility Name
Local Institution
City
Hualien
Country
Taiwan
Facility Name
Local Institution
City
Taichung
Country
Taiwan
Facility Name
Local Institution
City
Tainan
Country
Taiwan
Facility Name
Local Institution
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
18777489
Citation
Rubin CJ, Ledeine JM, Fiedorek FT. Improvement of glycaemic and lipid profiles with muraglitazar plus metformin in patients with type 2 diabetes: an active-control trial with glimepiride. Diab Vasc Dis Res. 2008 Sep;5(3):168-76. doi: 10.3132/dvdr.2008.028.
Results Reference
derived

Learn more about this trial

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

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