Dataset from 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.