A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics
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
1 other identifier
interventional
1,159
4 countries
85
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedSeptember 14, 2010
June 1, 2008
1.4 years
October 17, 2005
September 10, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin
Secondary Outcomes (2)
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
hs-CRP from baseline to W24
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Local Institution
Birmingham, Alabama, United States
Local Institution
Columbiana, Alabama, United States
Local Institution
Mesa, Arizona, United States
Local Institution
Peoria, Arizona, United States
Local Institution
Carlisle, Arkansas, United States
Local Institution
Jonesboro, Arkansas, United States
Local Institution
Little Rock, Arkansas, United States
Local Institution
Pine Bluff, Arkansas, United States
Local Institution
Sherwood, Arkansas, United States
Local Institution
Anaheim, California, United States
Local Institution
Artesia, California, United States
Local Institution
Encino, California, United States
Local Institution
Encintas, California, United States
Local Institution
Fresno, California, United States
Local Institution
Long Beach, California, United States
Local Institution
Los Angeles, California, United States
Local Institution
Northridge, California, United States
Local Institution
Denver, Colorado, United States
Local Institution
Hamden, Connecticut, United States
Local Institution
Altamonte Springs, Florida, United States
Local Institution
Hollywood, Florida, United States
Local Institution
Jacksonville, Florida, United States
Local Institution
Miami, Florida, United States
Local Institution
New Port Richie, Florida, United States
Local Institution
Saint Cloud, Florida, United States
Local Institution
West Palm Beach, Florida, United States
Local Institution
Honolulu, Hawaii, United States
Local Institution
Evansville, Indiana, United States
Local Institution
Lafayette, Indiana, United States
Local Institution
New Orleans, Louisiana, United States
Local Institution
Shreveport, Louisiana, United States
Local Institution
Baltimore, Maryland, United States
Local Institution
Detroit, Michigan, United States
Local Institution
Gulfport, Mississippi, United States
Local Institution
St Louis, Missouri, United States
Local Institution
Omaha, Nebraska, United States
Local Institution
Endwell, New York, United States
Local Institution
Cary, North Carolina, United States
Local Institution
Charlotte, North Carolina, United States
Local Institution
Raleigh, North Carolina, United States
Local Institution
Rudd, North Carolina, United States
Local Institution
Statesville, North Carolina, United States
Local Institution
Wilmington, North Carolina, United States
Local Institution
Winston-Salem, North Carolina, United States
Local Institution
Bellbrook, Ohio, United States
Local Institution
Maumee, Ohio, United States
Local Institution
Thornville, Ohio, United States
Local Institution
Oklahoma City, Oklahoma, United States
Local Institution
Portland, Oregon, United States
Local Institution
Camp Hill, Pennsylvania, United States
Local Institution
Melrose Park, Pennsylvania, United States
Local Institution
Pittsburgh, Pennsylvania, United States
Local Institution
West Chester, Pennsylvania, United States
Local Institution
Youngwood, Pennsylvania, United States
Local Institution
East Providence, Rhode Island, United States
Local Institution
Charleston, South Carolina, United States
Local Institution
Clinton, South Carolina, United States
Local Institution
Memphis, Tennessee, United States
Local Institution
Austin, Texas, United States
Local Institution
Carrollton, Texas, United States
Local Institution
Corpus Christi, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Houston, Texas, United States
Local Institution
Midland, Texas, United States
Local Institution
San Antonio, Texas, United States
Local Institution
Salt Lake City, Utah, United States
Local Institution
Lebanon, Virginia, United States
Local Institution
Spokane, Washington, United States
Local Institution
Tacoma, Washington, United States
Local Institution
Bluefield, West Virginia, United States
Local Institution
Red Deer, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Sarnia, Ontario, Canada
Local Institution
Bonaventure, Quebec, Canada
Local Institution
Drummondville, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Rimouski, Quebec, Canada
Local Institution
Aguascalientes, Aguascalientes, Mexico
Local Institution
Chihuahua City, Chihuahua, Mexico
Local Institution
Mexico, Durango, Mexico
Local Institution
Tijuana, Estado de Baja California, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Cuernavaca, Morelos, Mexico
Local Institution
Aguas Buenas, Puerto Rico
Local Institution
Ponce, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 18, 2005
Study Start
October 1, 2003
Primary Completion
March 1, 2005
Last Updated
September 14, 2010
Record last verified: 2008-06