Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

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:

Arms:
arm 1: Empagliflozin low dose tablet once daily arm 2: Empagliflozin high dose tablet once daily arm 3: Placebo tablet once daily

Interventions: intervention 1: Placebo intervention 2: Empagliflozin intervention 3: Placebo intervention 4: Placebo intervention 5: Empagliflozin intervention 6: Placebo
Intervention descriptions: intervention 1: Placebo tablet matching Empagliflozin low dose intervention 2: Empagliflozin low dose intervention 3: Placebo tablet matching Empagliflozin high dose intervention 4: Placebo tablet matching Empagliflozin low dose intervention 5: Empagliflozin high dose tablet once daily intervention 6: Placebo tablet matching Empagliflozin high dose

Protocol document: