A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics - Full Text View

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Muraglitazar	Phase III

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride Muraglitazar

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin

Secondary Outcome Measures:

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

Estimated Enrollment:	1159
Study Start Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240370

Show 85 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CV168-025
First Received:	October 17, 2005
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00240370
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases

Pioglitazone

Metformin

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00240370