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Clinical Trial Details

Trial ID: L3752
Source ID: NCT00762112
Associated Drug: Tak-559
Title: 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
Outcome Measures: Primary: Change from baseline in clinical laboratory hematology tests., Week 2 and Months 6, 12, 18, and Final Visit|Change from baseline in clinical laboratory chemistry tests., Week 2 and Months 6, 12, 18, and Final Visit|Blood pressure measurements., All visits.|Pulse measurements., All visits.|Body weight., All visits.|Physical examinations., Months 6, 12, 18, and Final Visit|12-lead electrocardiogram., Months 6, 12, and Final Visit|Adverse event occurrence., All visits or at occurrence | Secondary: Change from baseline in glycosylated hemoglobin., Months 3, 6, 9, 12, 15, 18, 21, and Final Visit|Change from baseline in fasting plasma glucose., All visits.|Change from baseline in fasting insulin., Months 3, 6, 9, 12, 15, 18, 21, and Final Visit|Change from baseline in fasting C-peptide., Months 6, 12, 18, and Final Visit|Change from baseline in triglycerides., Months 6, 12, 18, and Final Visit|Change from baseline in total cholesterol., Months 6, 12, 18, and Final Visit|Change from baseline in high-density lipoprotein., Months 6, 12, 18, and Final Visit|Change from baseline in low-density lipoprotein., Months 6, 12, 18, and Final Visit|Change from baseline in very-low-density lipoprotein., Months 6, 12, 18, and Final Visit|Change from baseline in low-density lipoprotein fractionation., Months 6, 12, 18, and Final Visit|Change from baseline in intermediate-density lipoprotein size., Months 6, 12, 18, and Final Visit|Change from baseline in large low-density lipoprotein size., Months 6, 12, 18, and Final Visit|Change from baseline in small low-density lipoprotein size., Months 6, 12, 18, and Final Visit|Change from baseline in medium-small low-density lipoprotein size., Months 6, 12, 18, and Final Visit|Change from baseline in very-small low-density lipoprotein size., Months 6, 12, 18, and Final Visit|Change from baseline in mean low-density lipoprotein size., Months 6, 12, 18, and Final Visit|Change from baseline in apolipoproteins A1 and B., Months 12 and Final Visit|Change from baseline in atherosclerosis marker plasminogen activator inhibitor 1., Months 6, 12, and Final Visit|Change from baseline in atherosclerosis marker fibrinogen., Months 6, 12, and Final Visit|Change from baseline in inflammation marker Interleukin-6., Months 6, 12, and Final Visit|Change from baseline in inflammation marker C-reactive protein., Months 6, 12, and Final Visit
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 316
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|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/NCT00762112