The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM

Sponsor
AstraZeneca
Study ID
NCT02582840
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 5mg — DRUG
    Dapagliflozin, a blood glucose lowering drug. Oral dose
  • Dapagliflozin 10mg — DRUG
    Dapagliflozin, a blood glucose lowering drug. Oral dose
  • Placebo tablet — DRUG
    Placebo tablet. Oral dose

Study Details

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.

Key Dates

Start date
Oct 31, 2015
Status verified
Aug 2018
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: dapagliflozin 5mg
    dapagliflozin tablet 5mg
  • Experimental: dapagliflozin 10mg
    dapagliflozin tablet 10mg
  • Placebo Comparator: Placebo
    dapagliflozin tablet 5mg placebo or 10 mg placebo

Primary Outcome Measure

Dapagliflozin Maximum Observed Plasma Concentration (Cmax) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set [ Time Frame: Day 1-7 ]

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