A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating PEGylated Loxenatide Injection（PEX168）Combined With Metformin in the Treatment of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 587
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study that will enroll approximately 564 T2DM patients who before screening have inadequately controlled blood glucose （7.0%≤HbA1c≤10.5% at randomization）despite at least 8 weeks of metformin monotherapy at stable doses（≥1500 mg/day).
详细描述
Subjects will be randomized to receive either PEX168 100μg, 200μg or PEX 168 Dummy Injection as add-on to metformin hydrochloride. The baseline HbA1c level （HbA1c≤8.5% or HbA1c>8.5）is designed as the stratification factor based on which a dynamic randomization will be performed.
This study consists of 4 periods： Period 1：Up to 3 weeks of screening period. Period 2：A 4-week PEX168 dummy injection run-in period. Period 3：A 52-week treatment period (including a 24-week core treatment period and a 28-week extended treatment period).
Period 4: A 30-day safety follow-up period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PEX168(100µg)
PEX168,100µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
干预措施: PEX168(100µg) (Drug)
PEX168(100µg)
PEX168,100µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
干预措施: Metformin (Drug)
PEX168(200µg)
PEX168,200µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
干预措施: PEX168(200µg) (Drug)
PEX168(200µg)
PEX168,200µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
干预措施: Metformin (Drug)
Placebo
Placebo,0.5ml,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
干预措施: Placebo (Drug)
Placebo
Placebo,0.5ml,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
干预措施: Metformin (Drug)
结局指标
主要结局
HbA1c
时间窗: Baseline to Week24
HbA1c change from baseline to treatment Week 24 when receiving PEX 168 combined with metformin hydrochloride as compared to the placebo combined with metformin hydrochloride；PEX 168 as compared to the placebo, given on the basis of diet control and exercise.
次要结局
- The proportion of HbA1c <6.5% and <7% at the end of the analysis.(Baseline to Week24)
- Fasting plasma glucose(Baseline to Week52)
- 6 points glucose of fingertip(Baseline to Week52)
- Postprandial blood glucose two hours(Baseline to Week52)
- Postprandial blood glucose two hours AUC(Baseline to Week52)
- Lipid(Baseline to Week52)
- Weight measured by standardized procedure.(Baseline to Week52)
- Blood pressure(Baseline to Week52)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Baseline to Week 56)