| Trial ID: | L5670 |
| Source ID: | NCT01387737
|
| Associated Drug: |
Ta-7284-Low
|
| Title: |
Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01387737/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: TA-7284-Low|DRUG: TA-7284-High
|
| Outcome Measures: |
Primary: Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, 54 weeks | Secondary: Change in HbA1c, Week 52|Change in Fasting Plasma Glucose, Week 52|Change in Body Weight, Week 52|Change in Blood Pressure, Week 52
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
1299
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-05
|
| Completion Date: |
2012-12
|
| Results First Posted: |
2014-04-28
|
| Last Update Posted: |
2014-06-06
|
| Locations: |
Research site, Chugoku, Japan|Research site, Hokkaido, Japan|Research site, Kanto, Japan|Research site, Kinki, Japan|Research site, Kyushu, Japan|Research site, Shikoku, Japan|Research site, Tohoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01387737
|