NCT01257412暂停3 期
A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- AstraZeneca
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- change in glycosylated haemoglobin A1c (HbA1c).
研究概览
简要总结
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent before participating in the study
- •Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0%
- •Subjects should be drug naïve
- •Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative serum or urine pregnancy test
排除标准
- •Subjects received Insulin therapy within one year of enrollment
- •Subjects who have severe uncontrolled hypertension
- •Subjects who have history of unstable or rapidly progressing renal disease
- •Subjects who have severe liver disease
- •Subjects who receiving treatment for Human immunodeficiency virus (HIV)
研究组 & 干预措施
1
Experimental
干预措施: Dapagliflozin (Drug)
2
Experimental
干预措施: Dapagliflozin (Drug)
3
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
change in glycosylated haemoglobin A1c (HbA1c).
时间窗: From baseline to week 24
次要结局
- mean change from baseline in fasting plasma glucose (FPG)(From baseline to week 1)
- mean change in fasting plasma glucose (FPG)(From baseline to week 24)
- mean change in 2- hour postprandial glucose by Mixed Meal Test(From baseline to week 24)
研究者
研究点 (1)
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