FindTrial
Sign In

A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase 3 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

A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase 3 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
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221432
Enrollment
Unknown
Registered
2011-04-18
Start date
2011-04-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Interventions

investigational material(s) Generic name etc : Dapagliflozin INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational materi

Sponsors

AstraZeneca
Lead Sponsor
Bristol-Myers Squibb
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Provision of informed consent prior to any study specific procedures - Men or women age 20 years old or more (Either gender needs to be 40% or higher of total number of treated subjects) - Diagnosed with type2 DM

Exclusion criteria

Exclusion criteria: - Type 1 diabetes mellitus - FPG more than 240 mg/dL before randomization - Subjects who have history of unstable or rapidly progressing renal disease - Subjects who have severe hepatic insufficiency and/or significant abnormal liver function - Significant cardiovascular history

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026