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Clinical Trial Details

Trial ID: L3364
Source ID: NCT00763022
Associated Drug: Tak-559
Title: Efficacy of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: TAK-559|DRUG: TAK-559|DRUG: Placebo
Outcome Measures: Primary: Change in Baseline in Glycosylated hemoglobin., Weeks: 4, 8, 12, 16, 20 and Final Visit. | Secondary: Change in Baseline in Glycosylated hemoglobin., Weeks: 4, 8, 12, 16, 20 and Final Visit.|Change in Baseline in Fasting Plasma Glucose., Weeks: 2, 4, 8, 12, 16, 20 and Final Visit.|Change in Baseline in Serum insulin., Weeks: 4, 12, 16, 20 and Final Visit.|Change in Baseline in C-peptide., Weeks: 4, 12, 16, 20 and Final Visit.|Change in Baseline in Lipids (triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, very-low-density lipoprotein)., Weeks: 12, 16, 20 and Final Visit.|Change in Baseline in Lipids (low-density lipoprotein fractionation)., Weeks: 12, 16, 20 and Final Visit.|Change in Baseline in Apolipoproteins Al and B100., Final Visit.|Change in Baseline in Free fatty acids., Weeks: 12, 16, 20 and Final Visit.|Markers of thrombosis (plasminogen activator inhibitor-i)., Weeks: 4, 12, 16, 20 and Final Visit.|Markers of thrombosis (fibrinogen)., Weeks: 4, 12, 16, 20 and Final Visit.|Markers of inflammation (interleukin-6)., Weeks: 4, 12, 16, 20 and Final Visit.|Markers of inflammation (C-reactive protein)., Weeks: 4, 12, 16, 20 and Final Visit.|Urinary albumin/creatinine ratio., Weeks: 12, 16, 20 and Final Visit.
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 302
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2003-11
Completion Date: 2004-12
Results First Posted:
Last Update Posted: 2012-11-12
Locations:
URL: https://clinicaltrials.gov/show/NCT00763022