A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) and Safety of rE-4 in Subjects With Type 2 Diabetes Mellitus Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 456
- 主要终点
- Change in HbA1c from Baseline to Week 30
研究概览
简要总结
This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial.
详细描述
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of rE-4 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two rE-4 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin, a sulfonylurea or metformin and a sulfonylurea combination) throughout the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7.0% ≤ HbA1c ≤ 11.0% at screening
- •FPG ≤13.8 mmol/L
- •19 kg/m2 < BMI <35.0 kg/m2 at screening
- •All subjects provided written informed consent before participation
排除标准
- •Patients treated previously with Exenatide or GLP-1 similar
- •At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 2.5 ULN
- •At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or Triglyceride(TG)≥ 5 mmol/L
- •Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases
- •Within the last 12 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period
- •History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones)
- •Patients with severe renal impairment or end-stage renal disease
- •Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit.
- •Use of weight loss drugs within 3 months prior to screening visit
- •Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4 inhibitor or pramlintide acetate within the 3 months prior to screening.
- •Severe gastrointestinal disease (e.g., gastroparesis)
- •Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
- •Participant who participated in any drug clinical trial within the last 3 months prior to screening visit
- •History of severe hypersensitivity to rExenatide-4 or any product components
研究组 & 干预措施
rE-4 5 mcg
Placebo, then rE-4 5 mcg, then rE-4 5 mcg
干预措施: rE-4 5 mcg (Biological)
rE-4 10 mcg
Placebo, then rE-4 5 mcg, then rE-4 10 mcg
干预措施: rE-4 10 mcg (Biological)
Placebo 5 mcg
Placebo 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg
干预措施: Placebo 5 mcg (Biological)
Placebo 10 mcg
Placebo 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg
干预措施: Placebo 10 mcg (Biological)
结局指标
主要结局
Change in HbA1c from Baseline to Week 30
时间窗: Baseline (Day 1) to Week 30
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
次要结局
- The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30(Baseline (Day 1) and Week 30)
- Change in body weight from Baseline to each intermediate visit and Week 30(Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30)
- Change in FPG from Baseline to each intermediate visit and Week 30(Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30)
- Change in 7-SMBG from Baseline to Week 16，Week 24 and Week 30(Baseline, Week 16，Week 24 and Week 30)