A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of YYC405-T Added to Metformin and Dapagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With the Combination of Metformin and Dapagliflozin
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients
详细描述
Phase 3 study to assess the Efficacy and Safety of YYC405-T when added to Metformin and Dapagliflozin combination therapy in patients with type 2 diabetes mellitus 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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who contsent to participate in this tiral by written informed consent form
- •A man or woman over 20 years old
- •Type 2 Diabetes patients
排除标准
- •Patients with severe renal impairment, end-stage renal disease or on dialysis
- •Type 1 diabetes patients
- •Patients with a history of acute or chronic target acidosis, including lactic acidosis and diabetic ketoacidosis
研究组 & 干预措施
Test
Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
干预措施: YYC405-T (Drug)
Test
Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
干预措施: Metformin≥1000mg (Drug)
Test
Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
干预措施: Dapagliflozin 10mg (Drug)
Placebo control
Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg
干预措施: Metformin≥1000mg (Drug)
Placebo control
Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg
干预措施: Dapagliflozin 10mg (Drug)
Placebo control
Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg
干预措施: YYC405-T placebo (Drug)
结局指标
主要结局
HbA1c
时间窗: Baseline, 24 weeks
Change from baseline in Glycosylated Hemoglobin (HbA1c)
次要结局
- C-peptide(Baseline, 12weeks, 24weeks)
- FPG, Fasting insulin(Baseline, 12weeks, 24weeks)
- HbA1c(Baseline, 12weeks)