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
Phase 3
- Conditions
- Diabetes Mellitus
- Registration Number
- JPRN-jRCT2080221432
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method