Dataset from A 28-day Randomised, Placebo-controlled, Double-blind Parallel Group Phase IIa Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once Daily Oral Doses of 2.5 mg, 10 mg, and 25 mg Empagliflozin as Adjunctive to Insulin in Patients With Type 1 Diabetes Mellitus (EASE-2)

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.