The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will
enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate
glycemic control on insulin defined as HbA1c ≥ 7.0% and ≤ 10.0% at screening visit.
lacebo-controlled design. Patients will be randomized in a 1:1:1 ratio into one of the 3
single-blinded treatment arms; dapagliflozin 5 mg, dapagliflozin 10 mg or placebo. CSII user
are excluded.