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

NCT ID: NCT00240370

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Muraglitazar

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Birmingham, Alabama, United States

Site Status

Local Institution

Columbiana, Alabama, United States

Site Status

Local Institution

Mesa, Arizona, United States

Site Status

Local Institution

Peoria, Arizona, United States

Site Status

Local Institution

Carlisle, Arkansas, United States

Site Status

Local Institution

Jonesboro, Arkansas, United States

Site Status

Local Institution

Little Rock, Arkansas, United States

Site Status

Local Institution

Pine Bluff, Arkansas, United States

Site Status

Local Institution

Sherwood, Arkansas, United States

Site Status

Local Institution

Anaheim, California, United States

Site Status

Local Institution

Artesia, California, United States

Site Status

Local Institution

Encino, California, United States

Site Status

Local Institution

Encintas, California, United States

Site Status

Local Institution

Fresno, California, United States

Site Status

Local Institution

Long Beach, California, United States

Site Status

Local Institution

Los Angeles, California, United States

Site Status

Local Institution

Northridge, California, United States

Site Status

Local Institution

Denver, Colorado, United States

Site Status

Local Institution

Hamden, Connecticut, United States

Site Status

Local Institution

Altamonte Springs, Florida, United States

Site Status

Local Institution

Hollywood, Florida, United States

Site Status

Local Institution

Jacksonville, Florida, United States

Site Status

Local Institution

Miami, Florida, United States

Site Status

Local Institution

New Port Richie, Florida, United States

Site Status

Local Institution

Saint Cloud, Florida, United States

Site Status

Local Institution

West Palm Beach, Florida, United States

Site Status

Local Institution

Honolulu, Hawaii, United States

Site Status

Local Institution

Evansville, Indiana, United States

Site Status

Local Institution

Lafayette, Indiana, United States

Site Status

Local Institution

New Orleans, Louisiana, United States

Site Status

Local Institution

Shreveport, Louisiana, United States

Site Status

Local Institution

Baltimore, Maryland, United States

Site Status

Local Institution

Detroit, Michigan, United States

Site Status

Local Institution

Gulfport, Mississippi, United States

Site Status

Local Institution

St Louis, Missouri, United States

Site Status

Local Institution

Omaha, Nebraska, United States

Site Status

Local Institution

Endwell, New York, United States

Site Status

Local Institution

Cary, North Carolina, United States

Site Status

Local Institution

Charlotte, North Carolina, United States

Site Status

Local Institution

Raleigh, North Carolina, United States

Site Status

Local Institution

Rudd, North Carolina, United States

Site Status

Local Institution

Statesville, North Carolina, United States

Site Status

Local Institution

Wilmington, North Carolina, United States

Site Status

Local Institution

Winston-Salem, North Carolina, United States

Site Status

Local Institution

Bellbrook, Ohio, United States

Site Status

Local Institution

Maumee, Ohio, United States

Site Status

Local Institution

Thornville, Ohio, United States

Site Status

Local Institution

Oklahoma City, Oklahoma, United States

Site Status

Local Institution

Portland, Oregon, United States

Site Status

Local Institution

Camp Hill, Pennsylvania, United States

Site Status

Local Institution

Melrose Park, Pennsylvania, United States

Site Status

Local Institution

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution

West Chester, Pennsylvania, United States

Site Status

Local Institution

Youngwood, Pennsylvania, United States

Site Status

Local Institution

East Providence, Rhode Island, United States

Site Status

Local Institution

Charleston, South Carolina, United States

Site Status

Local Institution

Clinton, South Carolina, United States

Site Status

Local Institution

Memphis, Tennessee, United States

Site Status

Local Institution

Austin, Texas, United States

Site Status

Local Institution

Carrollton, Texas, United States

Site Status

Local Institution

Corpus Christi, Texas, United States

Site Status

Local Institution

Dallas, Texas, United States

Site Status

Local Institution

Houston, Texas, United States

Site Status

Local Institution

Midland, Texas, United States

Site Status

Local Institution

San Antonio, Texas, United States

Site Status

Local Institution

Salt Lake City, Utah, United States

Site Status

Local Institution

Lebanon, Virginia, United States

Site Status

Local Institution

Spokane, Washington, United States

Site Status

Local Institution

Tacoma, Washington, United States

Site Status

Local Institution

Bluefield, West Virginia, United States

Site Status

Local Institution

Red Deer, Alberta, Canada

Site Status

Local Institution

Vancouver, British Columbia, Canada

Site Status

Local Institution

Sarnia, Ontario, Canada

Site Status

Local Institution

Bonaventure, Quebec, Canada

Site Status

Local Institution

Drummondville, Quebec, Canada

Site Status

Local Institution

Montreal, Quebec, Canada

Site Status

Local Institution

Rimouski, Quebec, Canada

Site Status

Local Institution

Aguascalientes, Aguascalientes, Mexico

Site Status

Local Institution

Chihuahua City, Chihuahua, Mexico

Site Status

Local Institution

Mexico, Durango, Mexico

Site Status

Local Institution

Tijuana, Estado de Baja California, Mexico

Site Status

Local Institution

Mexico City, Mexico City, Mexico

Site Status

Local Institution

Cuernavaca, Morelos, Mexico

Site Status

Local Institution

Aguas Buenas, , Puerto Rico

Site Status

Local Institution

Ponce, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Mexico Puerto Rico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CV168-025

Identifier Type: -

Identifier Source: org_study_id