Conditions: Type 1 Diabetes Mellitus
Keywords: Japanese patients with type 1 diabetes with inadequate glycemic control on insulin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: dapagliflozin tablet 5mg arm 2: dapagliflozin tablet 10mg arm 3: dapagliflozin tablet 5mg placebo or 10 mg placebo

Interventions: intervention 1: Dapagliflozin 5mg intervention 2: Dapagliflozin 10mg intervention 3: Placebo tablet
Intervention descriptions: intervention 1: Dapagliflozin, a blood glucose lowering drug. Oral dose intervention 2: Dapagliflozin, a blood glucose lowering drug. Oral dose intervention 3: Placebo tablet. Oral dose

Protocol document: