Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- The Changes in HbA1c at Week 24
研究概览
简要总结
This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with metformin.
研究设计
- 研究类型
- Interventional
- 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
- •A signed and dated informed consent form obtained from the subject, in accordance.
- •The subject is aged ≥18 years at signature of the informed consent form.
- •Hospitalization status: outpatient.
- •The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
- •The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
- •The subject's HbA1c is ≥ 7.0% and < 10.0% at the screening visit (Day -28) and on Day -14.
排除标准
- •The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
- •The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (< 2 weeks' duration).
- •The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).
研究组 & 干预措施
Teneligliptin 20mg
Teneligliptin (20mg once daily) for 24 weeks in combination with metformin
干预措施: Teneligliptin 20mg (Drug)
Teneligliptin 20mg
Teneligliptin (20mg once daily) for 24 weeks in combination with metformin
干预措施: Metformin ≥ 1000 mg (Drug)
Placebo
Placebo for 24 weeks in combination with metformin
干预措施: Placebo (Drug)
Placebo
Placebo for 24 weeks in combination with metformin
干预措施: Metformin ≥ 1000 mg (Drug)
结局指标
主要结局
The Changes in HbA1c at Week 24
时间窗: at Day 1(baseline) and Week 24
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
次要结局
- The Changes in Fasting Plasma Glucose (FPG) at Week 24(at Day 1(baseline) and Week 24)