| Trial ID: | L4813 |
| Source ID: | NCT01947855
|
| Associated Drug: |
Placebo
|
| Title: |
Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01947855/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Placebo|DRUG: Empagliflozin|DRUG: Placebo|DRUG: Placebo|DRUG: Empagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment, The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication., 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28 |
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-09
|
| Completion Date: |
2013-12
|
| Results First Posted: |
2014-12-24
|
| Last Update Posted: |
2014-12-24
|
| Locations: |
1245.35.002 Boehringer Ingelheim Investigational Site, Shinjyuku-ku, Tokyo, Japan|1245.35.001 Boehringer Ingelheim Investigational Site, Suita-shi, Osaka, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01947855
|
