Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT01947855
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin high dose Placebo Empagliflozin high dose tablet once daily Empagliflozin low dose Placebo Empagliflozin low dose tablet once daily Empagliflozin low dose Empagliflozin Empagliflozin low dose tablet once daily Placebo Placebo Placebo tablet once daily Empagliflozin high dose Empagliflozin Empagliflozin high dose tablet once daily
- Primary Outcome Measures
Name Time Method Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
1245.35.002 Boehringer Ingelheim Investigational Site
🇯🇵Shinjyuku-ku, Tokyo, Japan
1245.35.001 Boehringer Ingelheim Investigational Site
🇯🇵Suita-shi, Osaka, Japan