A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c (%) After 24 weeks
研究概览
简要总结
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
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
- •Patients with Type II diabetes mellitus aged 19 years or older
- •Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy
- •Subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit
- •Subjects who are receiving metformin ≥ 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit
- •Subjects with 7.0%≤HbA1c≤10.5% at screening visit
- •Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
- •Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit
排除标准
- •Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis
- •patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- •Patients with severe infectious disease or severe traumatic systemic disorders
- •End stage renal disease or dialysis patients
- •Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies
研究组 & 干预措施
Evogliptin 5mg group
Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
干预措施: Evogliptin 5mg (Drug)
Evogliptin 5mg group
Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
干预措施: Dapagliflozin 10mg (Drug)
Evogliptin 5mg group
Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
干预措施: Metformin ≥ 1000mg (Drug)
Evogliptin Placebo group
Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
干预措施: Evogliptin Placebo (Drug)
Evogliptin Placebo group
Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
干预措施: Dapagliflozin 10mg (Drug)
Evogliptin Placebo group
Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
干预措施: Metformin ≥ 1000mg (Drug)
结局指标
主要结局
Change from baseline in HbA1c (%) After 24 weeks
时间窗: 24 weeks
次要结局
- Change from baseline in FPG(mg/dL) After 24 weeks(24 weeks)
- Change from baseline in 7-point SMBG After 24 weeks(24 weeks)
- Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks(24 weeks)