Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin.

Sponsor
AstraZeneca
Study ID
NCT02157298
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and \< 11% will be enrolled into the wash-out phase or directly into the lead-in phase depending on whether the patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1 agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open extension treatment period.

Key Dates

Start date
Jun 30, 2014
Status verified
Mar 2016
Primary completion
Feb 28, 2015
Completion
Nov 30, 2015

Study Design

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

Arms

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

Primary Outcome Measure

Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 16 ]

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