A Multicenter, Randomized, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of PB-119 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy.
详细描述
This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not well-controlled by metformin monotherapy. Patients will be assessed for eligibility over a 2 week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119 or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will subsequently be given active drug and patients in placebo group will take placebo, all patients in two groups will remain metformin background therapy. In the 28-week open-label period, all patients will be administered active drugs. After that, there will be a 4-week follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic (PK) analysis.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18~75 years old;
- •T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,<1500mg) constantly for at least 8 consecutive weeks;
- •7.5% ≤ HbA1c ≤ 10.0% at screening;
- •18.5 kg/m2 < BMI < 40.0 kg/m2 at screening;
排除标准
- •Any anti-diabetic therapy other than Metformin within 8 weeks before screening；
- •Received insulin therapy more than 14 days within 1 year before screening;
- •Female who is pregnant, breast-feeding;
- •Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol;
- •History of acute diabetic complications, such as diabetic ketoacidosis or hyperglycemic hyperosmolar status within 6 months before screening；
- •History or presence of pancreatitis (acute or chronic);
- •Presence or history of malignant neoplasms within the past 5 years prior to the day of screening
研究组 & 干预措施
PB-119 once-weekly-subcutaneous injection
PB119 (polyethylene glycol exenatide) is a long-acting GLP-1RA for injection, which will be administered 150μg once-weekly subcutaneously to patients in active drug group for 24 weeks.
干预措施: GLP-1 receptor agonist (Drug)
Placebo once-weekly-subcutaneous injection
PB-119 150μg matched placebo which will be used in placebo group for 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: week 1, week 25
Change in HbA1c from baseline(week 1) to week 25
次要结局
- Change in Body Weight (kg)(week 1, week 25)
- Change in Body Mass Index(week 1, week 25)
- HbA1c Below 7.0%(week 1, week 25)
- Change in Fasting Plasma Glucose (FPG)(week 1, week 25)