| Trial ID: | L2813 |
| Source ID: | NCT01413204
|
| Associated Drug: |
Ta-7284 Low
|
| Title: |
Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01413204/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: TA-7284 Low|DRUG: TA-7284 High|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value), baseline and 24 weeks | Secondary: Change in Fasting Plasma Glucose, Week 24|Change in Body Weight, Week 24|Change in Blood Pressure, Week 24|Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test, Week 24|Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs, Week 24
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
272
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-07
|
| Completion Date: |
2012-08
|
| Results First Posted: |
2014-06-05
|
| Last Update Posted: |
2014-06-05
|
| Locations: |
Reserch site, Chubu, Japan|Reserch site, Kanto, Japan|Reserch site, Kinki, Japan|Reserch site, Shikoku, Japan|Reserch site, Tohoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01413204
|
