Available datapackage for study 'A Clinical Pharmacology and Long Term Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With Type 1 Diabetes Who Have Inadequate Glycemic Control'

This study will enroll eligible subjects into a long-term safety study (Part B).

Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic
control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5% at screening visit. As a condition of
enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3
months prior to the screening visit. The study design of Part B is a randomized, open-label,
2 arm, parallel-group design. 140 Japanese subjects in total will be randomized in a 1:1
ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.