Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Merck
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00106808
First received: March 31, 2005
Last updated: September 10, 2010
Last verified: September 2007
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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 3 |
| 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:
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
Show 197 Study LocationsSponsors and Collaborators
Bristol-Myers Squibb
Merck
More Information
Additional Information:
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 May 19, 2013