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Clinical Trial Details

Trial ID: L2229
Source ID: NCT00762957
Associated Drug: Tak-559 And Metformin
Title: Safety and Efficacy of TAK-559 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus.
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: TAK-559 and metformin|DRUG: TAK-559 and metformin|DRUG: Metformin
Outcome Measures: Primary: Change from baseline in glycosylated hemoglobin., Final Visit. | Secondary: Change from baseline in glycosylated hemoglobin., Weeks 2, 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 baseline 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: 15
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: 2012-02-28
Locations:
URL: https://clinicaltrials.gov/show/NCT00762957