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 1 clinical trial evaluating Dapagliflozin 5mg, Dapagliflozin 10mg, and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 42 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Dapagliflozin, a blood glucose lowering drug. Oral dose
Dapagliflozin, a blood glucose lowering drug. Oral dose
Placebo tablet. Oral dose