Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	Merck
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00106808

Purpose

The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Muraglitazar Drug: Pioglitazone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase 3, Randomized, Double-blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar (BMS-298585) Compared to Pioglitazone in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Muraglitazar

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change in HBA1c from baseline to Week 24

Secondary Outcome Measures:

Change for baseline in TG and HDL-C at Week 24
Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks

Estimated Enrollment:	1440
Study Start Date:	August 2005
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Type 2 Diabetes
HbA1c > = 8.0% and < = 12.0%
Serum triglyceride concentration < = 600 mg/dL
Fasting c-peptide > = 1.0 ng/ml
Body mass index < = 41 kg/m2
Drug naive patients

Exclusion Criteria:

History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase.
Women of child Bearing Potential
Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase.
History of renal disease, bladder cancer, pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106808

Show 197 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Merck

More Information

Additional 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00106808 History of Changes
Other Study ID Numbers:	CV168-062
Study First Received:	March 31, 2005
Last Updated:	September 10, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Type 2 Diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Glycine

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012