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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Placebo tablet matching Empagliflozin low dose
Empagliflozin low dose
Placebo tablet matching Empagliflozin high dose
1245.35.002 Boehringer Ingelheim Investigational Site
Shinjyuku-ku, Tokyo, Japan
1245.35.001 Boehringer Ingelheim Investigational Site
Suita-shi, Osaka, Japan
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.
Time frame: 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
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Placebo tablet matching Empagliflozin low dose
Empagliflozin high dose tablet once daily
Placebo tablet matching Empagliflozin high dose