NCT02916706已完成3 期
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus
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
- 254
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to 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).
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 has been obtained from the subject, in accordance with International Conference on Harmonisation guidelines on Good Clinical Practice (ICH GCP), before any screening or study related procedures take place.
- •The subject is aged ≥18 years at signature of the informed consent form.
- •Hospitalization status: outpatient.
- •The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
- •The subject is undergoing diet and exercise therapy, 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 glycosylated fraction of haemoglobin(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
Experimental
Teneligliptin (20mg once daily) for 24 weeks
干预措施: Teneligliptin 20mg (Drug)
Placebo
Placebo Comparator
Placebo for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to 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)
研究者
研究点 (1)
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