| Trial ID: | L4350 |
| Source ID: | NCT00722917
|
| Associated Drug: |
Tak-379
|
| Title: |
Efficacy and Safety of TAK-379 in Adult Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: TAK-379|DRUG: TAK-379|DRUG: TAK-379|DRUG: Pioglitazone|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from Baseline in Glycosylated Hemoglobin, Week 12 or Final Visit | Secondary: Change from baseline in glycosylated hemoglobin., Weeks 4 and 8 or Final Visit|Change from baseline in fasting plasma glucose., Weeks 1, 2, 4, 8 and 12 or Final Visit|Change from baseline in body weight., Weeks 4, 8 and 12 or Final Visit|Number of patients with elevation of alanine aminotransferase greater than three times the Upper Limit of Normal during treatment., Week 12 or Final Visit|Plasma concentrations of TAK-379 and its metabolite M-I via a sparse sampling population approach., Week 12 or Final Visit
|
| Sponsor/Collaborators: |
Sponsor: Takeda
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
323
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-07
|
| Completion Date: |
2009-04
|
| Results First Posted: |
|
| Last Update Posted: |
2016-06-22
|
| Locations: |
Artesia, California, United States|Norwalk, California, United States|Santa Ana, California, United States|Santa Monica, California, United States|Panama City, Florida, United States|Cranston, Rhode Island, United States|Dallas, Texas, United States|Houston, Texas, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00722917
|
