A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 597
- 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 glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.
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
- •Type 2 Diabetes
- •Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
- •Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%
排除标准
- •Type 1 Diabetes
- •Hepatic (liver) impairment
- •Renal (kidney) failure or dysfunction
研究组 & 干预措施
1
dapagliflozin 2.5mg + Glimepiride
干预措施: dapagliflozin (Drug)
1
dapagliflozin 2.5mg + Glimepiride
干预措施: Glimepiride (Drug)
1
dapagliflozin 2.5mg + Glimepiride
干预措施: metformin hydrochloride (Drug)
1
dapagliflozin 2.5mg + Glimepiride
干预措施: pioglitazone hydrochloride (Drug)
1
dapagliflozin 2.5mg + Glimepiride
干预措施: Rosiglitazone (Drug)
2
dapagliflozin 5mg + Glimepiride
干预措施: dapagliflozin (Drug)
2
dapagliflozin 5mg + Glimepiride
干预措施: Glimepiride (Drug)
2
dapagliflozin 5mg + Glimepiride
干预措施: metformin hydrochloride (Drug)
2
dapagliflozin 5mg + Glimepiride
干预措施: pioglitazone hydrochloride (Drug)
2
dapagliflozin 5mg + Glimepiride
干预措施: Rosiglitazone (Drug)
3
dapagliflozin 10mg + Glimepiride
干预措施: dapagliflozin (Drug)
3
dapagliflozin 10mg + Glimepiride
干预措施: Glimepiride (Drug)
3
dapagliflozin 10mg + Glimepiride
干预措施: metformin hydrochloride (Drug)
3
dapagliflozin 10mg + Glimepiride
干预措施: pioglitazone hydrochloride (Drug)
3
dapagliflozin 10mg + Glimepiride
干预措施: Rosiglitazone (Drug)
4
Placebo + Glimepiride
干预措施: Glimepiride (Drug)
4
Placebo + Glimepiride
干预措施: metformin hydrochloride (Drug)
4
Placebo + Glimepiride
干预措施: pioglitazone hydrochloride (Drug)
4
Placebo + Glimepiride
干预措施: Rosiglitazone (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 dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.
次要结局
- Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%(At Week 24)
- Adjusted Mean Change in Body Weight(Baseline to Week 24)
- Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise(Baseline to Week 24)
- Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2(Baseline to Week 24)
- Adjusted Mean Change in Fasting Plasma Glucose (FPG)(Baseline to Week 24)