Conditions: Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 75
Healthy volunteers: no

Brief summary:
Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label placebo run-in period before randomisation. Background insulin therapy will be kept stable during the first 7 days of the treatment period and will be freely adjusted thereafter.

Detailed description:

Arms:
arm 1: Empagliflozin low once daily arm 2: Empagliflozin medium once daily arm 3: Empagliflozin high once daily arm 4: Placebo once daily

Interventions: intervention 1: Empagliflozin medium placebo intervention 2: Empagliflozin low placebo intervention 3: Empagliflozin low placebo intervention 4: Empagliflozin high placebo intervention 5: Empagliflozin medium intervention 6: Empagliflozin medium placebo intervention 7: Empagliflozin high placebo intervention 8: Empagliflozin high placebo intervention 9: Empagliflozin medium placebo intervention 10: Empagliflozin low placebo intervention 11: Empagliflozin low intervention 12: Empagliflozin high
Intervention descriptions: intervention 1: Empagliflozin medium placebo intervention 2: Empagliflozin low placebo intervention 3: Empagliflozin low placebo intervention 4: Empagliflozin high placebo intervention 5: Empagliflozin medium intervention 6: Empagliflozin medium placebo intervention 7: Empagliflozin high placebo intervention 8: Empagliflozin high placebo intervention 9: Empagliflozin medium placebo intervention 10: Empagliflozin low placebo intervention 11: Empagliflozin low intervention 12: Empagliflozin high

Protocol document: