A Phase III, Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.
详细描述
The study included a maximum 2-week screening period, a 4-week single-blind introduction period, a 24-week double-blind treatment period, a 28-week open extension treatment period, and a 4-week safety follow-up period.
At the end of the single-blind entry period, eligible subjects were randomly assigned to two different administration groups in a 1:1 ratio and received a 24-week double-blind treatment.
All subjects who completed the double-blind treatment entered the open extension treatment phase.Open extension treatment with subcutaneous injection of 150μg PB-119 once a week for 28 weeks.
Safety follow-up was conducted 4 weeks after the end of treatment/completion of early exit visit in the open extension 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
- 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;
- •Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by WHO1999；
- •18.5 kg/m2 < BMI < 40.0 kg/m2 at screening;
- •7.5% ≤ HbA1c ≤ 11.0% at screening;
- •7.0% ≤ HbA1c ≤ 10.5% when the random;
- •18.5 kg/m2 < BMI < 40.0 kg/m2 during screening and before randomization
排除标准
- •Continuous use of insulin for more than 14 days within 1 year before screening or before randomization；
- •Treatment with any dipeptidylpeptidase 4 (DPP-4) inhibitor or glucose-dependent insulin-stimulating peptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor agonist prior to screening or randomized prior treatment；
- •Screening for any of the following heart diseases within the first 6 months or before randomization；
- •Patients whose hypertension was not effectively controlled during screening or before randomization (after resting ≥5 minutes, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；
- •Serum amylase or lipase >3×ULN or those with previous diagnosis of acute/chronic pancreatitis were screened or randomly screened；
- •Screening for severe trauma or infection that may affect glycemic control within the first month or before randomization；
- •A history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)；
- •Known to be allergic or intolerant to the study drug or metformin；
- •Female subjects during pregnancy or lactation.
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
- HbA1c Below 7.0%(week 1, week 25)
- Change in Body Weight (kg)(week 1, week 25)
- Change in Fasting Plasma Glucose (FPG)(week 1, week 25)
- Change in Body Mass Index(week 1, week 25)