A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes With Inadequate Glycaemic Control on Insulin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,240
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change in HbA1c Levels
研究概览
简要总结
This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes
- •Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs
排除标准
- •Type 1 Diabetes
- •Treatment with more than two additional oral antidiabetic drugs
- •Moderate and severe renal (kidney) failure or dysfunction
研究组 & 干预措施
1
2.5mg
干预措施: Dapagliflozin (Drug)
2
5mg
干预措施: Dapagliflozin (Drug)
3
10mg
干预措施: Dapagliflozin (Drug)
4
干预措施: Placebo (Drug)
结局指标
主要结局
Adjusted Mean Change in HbA1c Levels
时间窗: Baseline to Week 24
To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.
次要结局
- Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction(Baseline to Week 24)
- Adjusted Mean Change in Body Weight(Baseline to Week 24)
- Adjusted Mean Change in Calculated Mean Daily Insulin Dose(Baseline to Week 24)
- Adjusted Mean Change in Fasting Plasma Glucose (FPG)(Baseline to Week 24)