A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SHR117887 in Combination Therapy With Metformin in Patients With Type 2 Diabetes Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12
研究概览
简要总结
SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy 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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type 2 diabetes mellitus
- •Patients have been treated with metformin for at least 8 weeks and be on a stable dose of at least 1500mg daily prior to the screening visit
- •HbA1C：≥7.5% and ≤11.0% at screeing visit and at the end of run-in period
- •Age:≥20 and ≤70 years
- •BMI(body mass index):≥20 and ≤35 kg/m2
排除标准
- 未提供
研究组 & 干预措施
Placebo/Metformin
patients are administered oral tablets of placebo once daily and 500mg TID for 4 weeks at the run-in period. After randomized ,patients administer the drugs too.
干预措施: Placebo (Drug)
SHR117887 (50mg q.d)/Metformin
patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 50mg QD and metformin 500mg TID for 12 weeks.
干预措施: SHR117887 (Drug)
SHR117887 (100mg q.d)/Metformin
patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 100mg QD and metformin 500mg TID for 12 weeks.
干预措施: SHR117887 (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12
时间窗: 12 weeks
次要结局
- Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels(12 weeks)
- Change From Baseline in Fasting Plasma Glucose,insulin and C-peptide at Week 12(12 weeks)
- Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12(12 weeks)
- Change From Baseline in Body Weight at Week 12(12 weeks)