Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects
2020年1月21日 更新者：PegBio Co., Ltd.
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of Twelve Once-weekly Subcutaneous Doses of PB-119 in Drug-naïve Subjects With Type 2 Diabetes Mellitus
This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.
研究概览
详细说明
Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period.
The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C).
Each patient will subsequently be randomized within the designated cohort to active drug or placebo at a 3:1 active drug:placebo ratio.
研究类型
介入性
注册 (实际的)
251
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Peking、中国、100000
- Peking University People's Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males and/or females between the ages of ≥18 and ≤70 years at Screening
- Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria
- HbA1c ≥7.5% and ≤11% at Screening and at Week -1
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening
Exclusion Criteria:
- Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial
- Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
- Calcitonin ≥50 ng/L at screening
- Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2
- Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening
- Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this trial
- Blood amylase or lipase >3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening
- Serum creatinine ≥1.5 mg/dL (male patients) or ≥1.4 mg/dL (female patients), or estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 at Screening
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) at Screening and pre-randomization
- Severe cardiovascular diseases occurring within 6 months prior to screening
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：PB-119 75ug
PB-119 injection 75ug subcutaneously injected once-weekly for 12 weeks
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60 eligible patients will be included in this group
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实验性的：PB-119 150ug
PB-119 injection 150ug subcutaneously injected once-weekly for 12 weeks
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60 eligible patients will be included in this group
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实验性的：PB-119 200ug
PB-119 injection 200ug subcutaneously injected once-weekly for 12 weeks
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60 eligible patients will be included in this group
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安慰剂比较：placebo
placebo injection subcutaneously injected once-weekly for 12 weeks
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60 eligible patients will be included in this group
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of glycosylated hemoglobin(HbA1c)
大体时间：12 weeks
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Change of HbA1c from baseline value to end of treatment
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of patients achieving HbA1c <7%
大体时间：12 weeks
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Percentage of patients achieving HbA1c <7% at Week 12
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12 weeks
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Percentage of patients achieving HbA1c ≤6.5%
大体时间：12 weeks
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Percentage of patients achieving HbA1c ≤6.5% at Week 12
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12 weeks
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HbA1c
大体时间：2, 4, and 8 weeks
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Changes of HbA1c from baseline value at Weeks 2, 4, and 8
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2, 4, and 8 weeks
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Fasting plasma glucose(FPG)
大体时间：2, 4, 8, and 12 weeks
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Changes of fasting plasma glucose(FPG) from baseline value at Weeks 2, 4, 8, and 12.
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2, 4, 8, and 12 weeks
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2-hour postprandial glucose(2-h PPG)
大体时间：4, 8, and 12 weeks
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Changes of 2-hour postprandial glucose(2-h PPG) from baseline value at Weeks 4, 8, and 12.
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4, 8, and 12 weeks
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Insulin
大体时间：4, 8, and 12 weeks
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Changes of insulin from baseline value at Weeks 4, 8, and 12
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4, 8, and 12 weeks
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C-peptide
大体时间：4, 8, and 12 weeks
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Changes of C-peptide from baseline value at Weeks 4, 8, and 12
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4, 8, and 12 weeks
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Self-monitoring of blood glucose (SMBG)
大体时间：4, 8, and 12 weeks
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Changes of mean profile and mean increments from baseline value of the 7-point SMBG
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4, 8, and 12 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body mass index(BMI)
大体时间：2, 4, 8, and 12 weeks
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Changes of BMI from baseline value at Weeks 2, 4, 8, and 12.
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2, 4, 8, and 12 weeks
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Waist and hip circumferences and waist-to-hip ratio
大体时间：12 weeks
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Change of waist and hip circumferences and waist-to-hip ratio from baseline value at end of treatment(waist and hip circumferences will be used to calculate waist-to-hip ratio
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12 weeks
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Blood pressure(both systolic and diastolic)
大体时间：2, 4, 8, and 12 weeks
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Changes of blood pressure from baseline value at Weeks 2, 4, 8, and 12.
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2, 4, 8, and 12 weeks
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Blood lipid
大体时间：2, 4, 8, and 12 weeks
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Changes of blood lipid from baseline value at Weeks 2, 4, 8, and 12
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2, 4, 8, and 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Linong Ji, MD,PhD、Peking University People's Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
- Ji L, Du Y, Xu M, Zhou X, Mo Z, Ma J, Li J, Li Y, Lin J, Wang Y, Yang J, Song W, Jin H, Pang S, Liu H, Li P, Liu J, Yao M, Li W, Jiang X, Shen F, Geng H, Zhou H, Ran J, Lei M, Du Y, Ye S, Guan Q, Lv W, Tan H, Chen T, Yang J, Qin G, Li S, Chen L. Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study. Diabetologia. 2021 May;64(5):1066-1078. doi: 10.1007/s00125-021-05392-9. Epub 2021 Mar 9. Erratum In: Diabetologia. 2021 Aug;64(8):1900-1901.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年6月5日
初级完成 (实际的)
2019年7月29日
研究完成 (实际的)
2019年7月29日
研究注册日期
首次提交
2018年4月18日
首先提交符合 QC 标准的
2018年4月27日
首次发布 (实际的)
2018年5月11日
研究记录更新
最后更新发布 (实际的)
2020年1月22日
上次提交的符合 QC 标准的更新
2020年1月21日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
PB-119 75ug的临床试验
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University of South CarolinaDuke University; Kilimanjaro Christian Medical Centre, Tanzania完全的