Phase 2
Completed N=279
Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
Source: ClinicalTrials.gov NCT00972244 ↗Enrolled (actual)
279
Serious AEs
2.2%
Results posted
Oct 2013
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — -0.12; -0.10; -0.37; -0.44 percent — p=<0.0001
Summary
The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
-0.12; -0.10; -0.37; -0.44; 0.35 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Fasting Plasma Glucose |
-16.63; -19.97; -23.49; -31.92; 9.45 | <0.0001 sig |
| SECONDARY Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% |
1.7; 9.3; 5.2; 9.6; 1.9 | 1.0000 |
Eligibility Criteria
Inclusion Criteria
- Japanese Subjects with type 2 diabetes mellitus.
- Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
- Provision of informed consent.
Exclusion Criteria
- Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
- The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
Data sourced from ClinicalTrials.gov (NCT00972244). 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.