| Trial ID: | L1771 |
| Source ID: | NCT02220920
|
| Associated Drug: |
Canagliflozin (Ta-7284)
|
| Title: |
Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02220920/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Canagliflozin (TA-7284)|DRUG: Placebo|DRUG: Insulin
|
| Outcome Measures: |
Primary: Change in HbA1c From Baseline, baseline and Week 16 | Secondary: Change in Fasting Plasma Glucose, baseline and Week 16|Percent Change in Body Weight, baseline and Week 16|Change in Blood Pressure, baseline and Week 16|Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased", Week 16
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
146
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-08
|
| Completion Date: |
2015-07
|
| Results First Posted: |
2016-12-15
|
| Last Update Posted: |
2016-12-15
|
| Locations: |
Reserch site, Chubu, Japan|Reserch site, Chugoku, Japan|Reserch site, Hokkaido, Japan|Reserch site, Kanto, Japan|Reserch site, Kinki, Japan|Reserch site, Kyushu, Japan|Reserch site, Tohoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02220920
|
