At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin 5 mg and Dapagliflozin 10mg for Type 1 Diabetes Mellitus. Completed, enrolled 151 participants across 24 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Dapagliflozin, a blood glucose lowering drug. Oral dose
Dapagliflozin, a blood glucose lowering drug. Oral dose