Phase 3
Completed N=261
Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes · High Blood Sugar
Source: ClinicalTrials.gov NCT01294423 ↗
Enrolled (actual)
261
Serious AEs
0.8%
Results posted
Aug 2013
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — -0.41; -0.45; -0.06 Percent — p=<0.0001
Summary
This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
-0.41; -0.45; -0.06 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Fasting Plasma Glucose (FPG) |
-8.6; -13.7; 5.8 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Body Weight |
-2.13; -2.22; -0.84 | 0.0003 sig |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization
Exclusion Criteria
- Type 1 diabetes mellitus
- FPG >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
Data sourced from ClinicalTrials.gov (NCT01294423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.