A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240370
• Other study ID #: CV168-025
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2005
• Last updated: September 10, 2010
• Start date: October 2003

Study information

• Verified date: June 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1159
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Muraglitazar

Locations

Country	Name	City	State
Canada	Local Institution	Bonaventure	Quebec
Canada	Local Institution	Drummondville	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Red Deer	Alberta
Canada	Local Institution	Rimouski	Quebec
Canada	Local Institution	Sarnia	Ontario
Canada	Local Institution	Vancouver	British Columbia
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Chihuahua
Mexico	Local Institution	Cuernavaca	Morelos
Mexico	Local Institution	Mexico	Durango
Mexico	Local Institution	Mexico City	Distrito Federal
Mexico	Local Institution	Tijuana	Baja California
Puerto Rico	Local Institution	Aguas Buenas
Puerto Rico	Local Institution	Ponce
United States	Local Institution	Altamonte Springs	Florida
United States	Local Institution	Anaheim	California
United States	Local Institution	Artesia	California
United States	Local Institution	Austin	Texas
United States	Local Institution	Baltimore	Maryland
United States	Local Institution	Bellbrook	Ohio
United States	Local Institution	Birmingham	Alabama
United States	Local Institution	Bluefield	West Virginia
United States	Local Institution	Camp Hill	Pennsylvania
United States	Local Institution	Carlisle	Arkansas
United States	Local Institution	Carrollton	Texas
United States	Local Institution	Cary	North Carolina
United States	Local Institution	Charleston	South Carolina
United States	Local Institution	Charlotte	North Carolina
United States	Local Institution	Clinton	South Carolina
United States	Local Institution	Columbiana	Alabama
United States	Local Institution	Corpus Christi	Texas
United States	Local Institution	Dallas	Texas
United States	Local Institution	Denver	Colorado
United States	Local Institution	Detroit	Michigan
United States	Local Institution	East Providence	Rhode Island
United States	Local Institution	Encino	California
United States	Local Institution	Encintas	California
United States	Local Institution	Endwell	New York
United States	Local Institution	Evansville	Indiana
United States	Local Institution	Fresno	California
United States	Local Institution	Gulfport	Mississippi
United States	Local Institution	Hamden	Connecticut
United States	Local Institution	Hollywood	Florida
United States	Local Institution	Honolulu	Hawaii
United States	Local Institution	Houston	Texas
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Jonesboro	Arkansas
United States	Local Institution	Lafayette	Indiana
United States	Local Institution	Lebanon	Virginia
United States	Local Institution	Little Rock	Arkansas
United States	Local Institution	Long Beach	California
United States	Local Institution	Los Angeles	California
United States	Local Institution	Maumee	Ohio
United States	Local Institution	Melrose Park	Pennsylvania
United States	Local Institution	Memphis	Tennessee
United States	Local Institution	Mesa	Arizona
United States	Local Institution	Miami	Florida
United States	Local Institution	Midland	Texas
United States	Local Institution	Morehead	North Carolina
United States	Local Institution	New Orleans	Louisiana
United States	Local Institution	New Port Richie	Florida
United States	Local Institution	Northridge	California
United States	Local Institution	Oklahoma City	Oklahoma
United States	Local Institution	Omaha	Nebraska
United States	Local Institution	Peoria	Arizona
United States	Local Institution	Pine Bluff	Arkansas
United States	Local Institution	Pittsburgh	Pennsylvania
United States	Local Institution	Portland	Oregon
United States	Local Institution	Raleigh	North Carolina
United States	Local Institution	Salt Lake City	Utah
United States	Local Institution	San Antonio	Texas
United States	Local Institution	Sherwood	Arkansas
United States	Local Institution	Shreveport	Louisiana
United States	Local Institution	Spokane	Washington
United States	Local Institution	St. Cloud	Florida
United States	Local Institution	St. Louis	Missouri
United States	Local Institution	Statesville	North Carolina
United States	Local Institution	Tacoma	Washington
United States	Local Institution	Thornville	Ohio
United States	Local Institution	W Palm Beach	Florida
United States	Local Institution	West Chester	Pennsylvania
United States	Local Institution	Wilmington	North Carolina
United States	Local Institution	Winston-Salem	North Carolina
United States	Local Institution	Youngwood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin
Secondary	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
Secondary	hs-CRP from baseline to W24

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm