Phase 3
Completed N=728
Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus
Type2 Diabetes · High Blood Sugar
Source: ClinicalTrials.gov NCT01294436 ↗
Enrolled (actual)
728
Serious AEs
4.0%
Results posted
Sep 2013
Primary outcomePrimary: Proportion of Participants With Adverse Events — 79.1; 72.4 Percentage of participants
Summary
This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Adverse Events |
79.1; 72.4 | — |
| PRIMARY Proportion of Participants With Serious Adverse Events |
5.6; 3.1 | — |
| PRIMARY Proportion of Participants With At Least One Episode of Hypoglycemia |
2.4; 4.0 | — |
| PRIMARY Mean Change in Hematocrit |
2.17; 2.00 | — |
| PRIMARY Mean Change in Alanine Aminotransferase (ALT) |
-7.1; -5.4 | — |
| PRIMARY Mean Change in Aspartate Aminotransferase (AST) |
-3.9; -2.6 | — |
| PRIMARY Mean Change in Blood Urea Nitrogen (BUN) |
2.4; 2.3 | — |
| PRIMARY Mean Change in Magnesium |
0.05; 0.05 | — |
| PRIMARY Mean Change in Serum Uric Acid |
-0.61; -0.50 | — |
| PRIMARY Mean Change in Seated Heart Rate |
-0.4; 0.2 | — |
| PRIMARY Mean Change in Seated Diastolic Blood Pressure |
-2.9; -2.1 | — |
| PRIMARY Mean Change in Seated Systolic Blood Pressure |
-5.2; -3.9 | — |
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 type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started
Exclusion Criteria
- Type 1 diabetes mellitus,
- FPG >240 mg/dL before treatment started
- 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 (NCT01294436). 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.