| Trial ID: | L4310 |
| Source ID: | NCT02354235
|
| Associated Drug: |
Teneligliptin
|
| Title: |
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02354235/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Teneligliptin|DRUG: Canagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c), The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24., Baseline, 24 Weeks | Secondary: Change From Baseline in Fasting Plasma Glucose Level, The change from baseline in fasting plasma glucose level collected at Week 24., Baseline, 24 Weeks|Percentage Change in Body Weight From Baseline, The percentage change from baseline in body weight collected at Week 24., Baseline, 24 Weeks|Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG), The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24., 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks|Change From Baseline in 2-hour Postprandial Plasma Glucose Level, The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24., 2 Hours Postprandial, at Baseline and 24 Weeks
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
138
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-01
|
| Completion Date: |
2016-01
|
| Results First Posted: |
2018-08-16
|
| Last Update Posted: |
2018-11-01
|
| Locations: |
Reserch site, Kanto, Japan|Reserch site, Kinki, Japan|Reserch site, Tohoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02354235
|
