A Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Overview
- Phase
- Phase 3
- Intervention
- Dapagliflozin
- Conditions
- Type2 Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 728
- Locations
- 1
- Primary Endpoint
- Proportion of Participants With Adverse Events
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
Open label treatment
Intervention: Dapagliflozin
Outcomes
Primary Outcomes
Proportion of Participants With Adverse Events
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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