The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM

Sponsor
AstraZeneca
Study ID
NCT02582814
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 26, 2015
Status verified
Jan 2019
Primary completion
Jun 15, 2017
Completion
Jun 15, 2017

Study Design

Enrollment
151 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: dapagliflozin 5mg + insulin
    dapagliflozin tablet 5mg + adjustable insulin
  • Experimental: dapagliflozin 10mg + insulin
    dapagliflozin tablet 10mg + adjustable insulin

Primary Outcome Measure

Overall Adverse Event Summary [ Time Frame: From baseline to 52 weeks ]

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