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Clinical Trial Details

Trial ID: L5106
Source ID: NCT00762684
Associated Drug: Tak-559
Title: Efficacy and Safety Study of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: TAK-559|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in glycosylated hemoglobin., Final Visit. | Secondary: Change from baseline in glycosylated hemoglobin., Weeks 4, 8, 12, 16 and 20|Change from baseline in fasting plasma glucose., Weeks 2, 4, 8, 12, 16, 20 and Final Visit|Change from baseline in serum insulin., Weeks 4, 12, 16, 20 and Final Visit.|Change from baseline in C-peptide., Weeks 4, 12, 16, 20 and Final Visit.|Change from baseline in triglycerides., Weeks 12, 16, 20 and Final Visit.|Change from baseline in total cholesterol., Weeks 12, 16, 20 and Final Visit.|Change from baseline in high-density lipoprotein., Weeks 12, 16, 20 and Final Visit.|Change from baseline in low-density lipoprotein., Weeks 12, 16, 20 and Final Visit.|Change from baseline in very-low-density lipoprotein., Weeks 12, 16, 20 and Final Visit.|Change from base line in apolipoproteins A1 and B 100., Final Visit|Change from baseline in free fatty acids., Weeks 12, 16, 20 and Final Visit.|Change from baseline in thrombosis marker (plasminogen activator inhibitor-1), Weeks 4, 12, 16, 20 and Final Visit|Change from baseline in thrombosis marker (fibrinogen), Weeks 4, 12, 16, 20 and Final Visit|Change from baseline in inflammation marker (Interleukin-6)., Weeks 4, 12, 16, 20 and Final Visit|Change from baseline in inflammation marker (C-reactive protein)., Weeks 4, 12, 16, 20, and Final Visit|Change from baseline in urinary albumin to creatinine ratio., Weeks 12, 16, 20 and Final Visit
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 8
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2004-11
Completion Date: 2004-12
Results First Posted:
Last Update Posted: 2012-11-12
Locations:
URL: https://clinicaltrials.gov/show/NCT00762684