Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus
- Registration Number
- NCT01294436
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 728
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open label treatment Dapagliflozin -
- Primary Outcome Measures
Name Time Method Proportion of Participants With Adverse Events Long-term treatment up to 52 weeks To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events
Proportion of Participants With Serious Adverse Events Long-term treatment up to 52 weeks To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events
Proportion of Participants With At Least One Episode of Hypoglycemia Long-term treatment up to 52 weeks To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia
Mean Change in Hematocrit Baseline to Week 52 To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit
Mean Change in Alanine Aminotransferase (ALT) Baseline to Week 52 To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase
Mean Change in Aspartate Aminotransferase (AST) Baseline to Week 52 To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase
Mean Change in Blood Urea Nitrogen (BUN) Baseline to Week 52 To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen
Mean Change in Magnesium Baseline to Week 52 To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)
Mean Change in Serum Uric Acid Baseline to Week 52 To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid
Mean Change in Seated Heart Rate Baseline to Week 52 To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse
Mean Change in Seated Diastolic Blood Pressure Baseline to Week 52 To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure
Mean Change in Seated Systolic Blood Pressure Baseline to Week 52 To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇯🇵Toyama, Japan