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Clinical Trial Details

Trial ID: L5343
Source ID: NCT00521742
Associated Drug: Pioglitazone
Title: Efficacy of Pioglitazone Compared to Glyburide in Treating Subjects With Type 2 Diabetes Mellitus and Mild Cardiac Disease
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: Pioglitazone|DRUG: Glyburide|DRUG: Pioglitazone|DRUG: Glyburide
Outcome Measures: Primary: Change in the walking distance during a standardized 6-minute walk test., Weeks 2, 16, 24, 40, and 52 or Final Visit | Secondary: Morbidity and Mortality Due to Cardiovascular Events., At occurrence or Weeks 2, 4, 6, 8, 12, 16, 24, 32, 36, 40, 48, and 52 or Final Visit|Change in Cardiovascular Treatment Program., At occurrence or Weeks 2, 4, 6, 8, 12, 16, 24, 32, 36, 40, 48, and 52 or Final Visit|Change from Baseline in 12-lead Electrocardiogram Parameter (Ventricular Heart Rate), Weeks 24 and 52 or Final Visit|Change from Baseline in Electrocardiogram Parameter (Left Ventricular Mass), Week 52 or Final Visit|Change from Baseline in Electrocardiogram Parameter (Left Ventricular Ejection Fraction), Week 52 or Final Visit|Change from Baseline in Electrocardiogram Parameter (Cardiac Index), Week 52 or Final Visit|Change from Baseline in Electrocardiogram Parameter (Fractional Shortening), Week 52 or Final Visit|Change in Blood Pressure, Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 48, and 52 or Final Visit|Change in Heart Rate, Weeks 24 and 52 or Final Visit|Change in Body Weight, Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 48, and 52 or Final Visit
Sponsor/Collaborators: Sponsor: Takeda | Collaborators: Takeda Pharmaceuticals North America, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2001-03
Completion Date: 2003-01
Results First Posted:
Last Update Posted: 2012-02-28
Locations:
URL: https://clinicaltrials.gov/show/NCT00521742