NCT02096705已完成3 期
A 24-week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 477
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change in HbA1c From Baseline to Week 24
研究概览
简要总结
The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit
- •Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment
- •Inclusion criteria for randomization:
- •HbA1c ≥ 7.5 and ≤ 10.5% at Day -14
排除标准
- •Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment
- •History of diabetic ketoacidosis of hyperosmolar nonketotic coma
- •Clinically diagnosed Type 1 diabetes mellitus
- •Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
- •Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
- •History of unstable or rapidly progressing renal disease
- •History of severe hepatobiliary disease
- •Mallingancy within 5 years of the screening/enrollment visit
研究组 & 干预措施
Group 1: Dapagliflozin
Experimental
Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
干预措施: Dapagliflozin (Drug)
Group 2: Dapagliflozin Placebo
Placebo Comparator
Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
干预措施: Dapagliflozin Placebo (Drug)
结局指标
主要结局
Adjusted Mean Change in HbA1c From Baseline to Week 24
时间窗: Baseline (Day 1) and 24 weeks
The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.
次要结局
- Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24(Baseline (Day 1) and 24 weeks)
- Adjusted Mean Change in Body Weight From Baseline to Week 24(Baseline (Day 1) and 24 weeks)
- Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24(Baseline (Day 1) and 24 weeks)
研究者
研究点 (1)
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