NCT04356742已完成3 期
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change from the baseline in HbA1c (%) after 24 weeks
研究概览
简要总结
This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients with type II diabetes mellitus aged 19 years or older
- •Patients who had taken metformin(≥1000mg/day) and DPP(dipeptidyl peptidase)-4 inhibitor combination therapy(or complex is allowed) at the same dose for at least 8 weeks prior to the screening visit
- •Patients with fasting plasma glucose≤250mg/dL at the screening visit
- •Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
- •Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study
排除标准
- •Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
- •Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
- •Patients with severe infectious disease or severe traumatic systemic disorders
- •Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- •Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
- •Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit
研究组 & 干预措施
Dapagliflozin 10mg + Evogliptin 5mg + Metformin
Experimental
干预措施: Dapagliflozin 10mg (Drug)
Dapagliflozin 10mg + Evogliptin 5mg + Metformin
Experimental
干预措施: Evogliptin 5mg (Drug)
Dapagliflozin 10mg + Evogliptin 5mg + Metformin
Experimental
干预措施: Metformin≥1000mg (Drug)
Dapagliflozin Placebo + Evogliptin 5mg + Metformin
Placebo Comparator
干预措施: Placebo (Drug)
Dapagliflozin Placebo + Evogliptin 5mg + Metformin
Placebo Comparator
干预措施: Evogliptin 5mg (Drug)
Dapagliflozin Placebo + Evogliptin 5mg + Metformin
Placebo Comparator
干预措施: Metformin≥1000mg (Drug)
结局指标
主要结局
Change from the baseline in HbA1c (%) after 24 weeks
时间窗: Baseline, 24 weeks
次要结局
- Change from the baseline in weight after 24 weeks(Baseline, 24 weeks)
- Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks(Baseline, 24 weeks)
- Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks(Baseline, 24 weeks)
研究者
研究点 (1)
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