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Clinical Trial Details

Trial ID: L4720
Source ID: NCT00762190
Associated Drug: Tak-559 And Insulin
Title: 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 and insulin|DRUG: Insulin
Outcome Measures: Primary: Incidence of Adverse events., All visits or at occurrence.|Clinical safety lab tests., Weeks 12, 24, and Final Visit.|12-lead electrocardiogram., Weeks: 24 and Final Visit.|Urinalysis., Weeks: 12, 24, 36, 48 and Final Visit.|Change from Baseline in Blood pressure and pulse., At all visits.|Change from Baseline in Body weight., At all visits.|Left ventricular mass index by body surface area measured by echocardiogram., Weeks: 24 and Final Visit. | Secondary: Change from Baseline in total daily dose of insulin., At all visits.|Change from Baseline in triglycerides., Weeks: 24 and Final Visit.|Change from Baseline in cholesterol., Weeks 24 and Final Visit|Change from Baseline in total, high-density lipoproteins., Weeks: 24 and Final Visit.|Change from Baseline in low-density lipoproteins., Weeks 24 and Final Visit|Change from Baseline in low-density lipoprotein fractionation., Weeks 24 and Final Visit|Change from Baseline in very low-density lipoprotein., Weeks 24 and Final Visit|Change from Baseline in free fatty acids., Weeks 24 and Final Visit|Change from Baseline in apolipoproteins (AI, B)., Weeks 24 and Final Visit
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 348
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/NCT00762190