Study identifier:D1695C00001sub
ClinicalTrials.gov identifier:NCT02582840
EudraCT identifier:N/A
CTIS identifier:N/A
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
Type 1 Diabetes Mellitus
Phase 1
No
Dapagliflozin 5mg, Dapagliflozin 10mg, Placebo tablet
All
42
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verified 01 Aug 2018 by AstraZeneca
AstraZeneca
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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.
Location
Location
Fukuoka-shi, Japan
Arms | Assigned Interventions |
---|---|
Experimental: dapagliflozin 5mg dapagliflozin tablet 5mg | Drug: Dapagliflozin 5mg Dapagliflozin, a blood glucose lowering drug. Oral dose |
Experimental: dapagliflozin 10mg dapagliflozin tablet 10mg | Drug: Dapagliflozin 10mg Dapagliflozin, a blood glucose lowering drug. Oral dose |
Placebo Comparator: Placebo dapagliflozin tablet 5mg placebo or 10 mg placebo | Drug: Placebo tablet Placebo tablet. Oral dose |
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