JPRN-jRCT2080221432
Unknown
Phase 3
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
ConditionsDiabetes Mellitus
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- AstraZeneca
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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