| Trial ID: | L4431 |
| Source ID: | NCT02622113
|
| Associated Drug: |
Canagliflozin (Ta-7284)
|
| Title: |
Long-Term 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/NCT02622113/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Canagliflozin (TA-7284)|DRUG: Insulin
|
| Outcome Measures: |
Primary: Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events), Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks | Secondary: Change in Percentage of HbA1c, Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks|Change in Fasting Plasma Glucose, Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks|Percentage Change in Body Weight, Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
139
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-12
|
| Completion Date: |
2016-04
|
| Results First Posted: |
2019-03-14
|
| Last Update Posted: |
2019-04-10
|
| 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/NCT02622113
|
