Status:
COMPLETED
Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
1440 Patients enrolled
Trial Details
Trial ID
NCT00106808
Start Date
August 1 2005
End Date
August 1 2006
Last Update
September 14 2010
Active Locations (195)
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Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Madison, Alabama, United States
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Glendale, Arizona, United States