Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.

Detailed description:

Arms:
arm 1: patient to receive a BI 10773 low dose tablet and a placebo tablet once daily arm 2: patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily arm 3: patient to receive two tablets of BI 10773 middle dose once daily arm 4: patient to receive a BI 10773 high dose tablet and a placebo tablet once daily arm 5: patient to receive two tablets of placebo once daily

Interventions: intervention 1: Placebo (middle dose) intervention 2: Placebo intervention 3: BI 10773 intervention 4: BI 10773 intervention 5: BI 10773 intervention 6: Placebo (high dose) intervention 7: BI 10773 intervention 8: Placebo (low dose)
Intervention descriptions: intervention 1: Placebo tablets once a day intervention 2: Placebo tablets once a day intervention 3: BI 10773 middle dose tablets once a day intervention 4: BI 10773 high dose tablets once a day intervention 5: BI 10773 middle dose tablets once a day intervention 6: Placebo tablets once a day intervention 7: BI 10773 low dose tablets once a day intervention 8: Placebo tablets once a day

Protocol document: