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A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Trial Profile

A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2018

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At a glance

  • Drugs Dapagliflozin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Sponsors AstraZeneca
  • Most Recent Events

    • 01 Nov 2016 Results of a pooled post-hoc analysis of five phase IIb and 16 phase III studies (including this study) assessing frequency and characteristics of hypersensitivity adverse events, published in the Clinical Drug Investigation.
    • 23 Jun 2013 Primary endpoint 'Proportion-of-glycosylated-haemoglobin' has been met.
    • 23 Jun 2013 Results presented at the 73rd Annual Scientific Sessions of the American Diabetes Association.
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