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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 728
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Open label treatment
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Proportion of Participants With Adverse Events
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点