| Trial ID: | L5534 |
| Source ID: | NCT02081599
|
| Associated Drug: |
Teneli (Teneligliptin)
|
| Title: |
Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02081599/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Teneli (Teneligliptin)|DRUG: Placebo|DRUG: Insulin
|
| Outcome Measures: |
Primary: Change From Baseline in HbA1c, The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate., at Week 0 and Week 16 | Secondary: Change From Baseline in Fasting Plasma Glucose, The change from Baseline in Fasting Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate., at Week 0 and Week 16|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose, The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate., 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16|Change From Baseline in 2-hour Postprandial Plasma Glucose, The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate., at Week 0 and Week 16
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
148
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01
|
| Completion Date: |
2016-01
|
| Results First Posted: |
2017-01-05
|
| Last Update Posted: |
2017-09-19
|
| Locations: |
Investigational site, Chuo-ku, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02081599
|
