NCT01342042Unknown2 期
The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To compare treatment arms in terms of change from baseline to endpoint in HbA1c
研究概览
简要总结
This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes Mellitus will take part in the trial.
Subjects will randomly enter into one of three groups, administration daily twice, the period of is 84 days treatment. Subjects should be in hospital for pharmacokinetic studies in 1 d~ 8d, 30 d (if necessary)and 84 d, during 9 d ~ 83 d outpatient follow-up.
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
- None
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
- •18 ~ 75 years with T2DM in China;
- •HbA1c of 7% to 13%;
- •negative pregnancy test in females, all subjects have no family planning during the test and after the end within 3 months.
排除标准
- •HBsAg, HCV, HIV and syphilis test was positive;
- •any time FBG <6.1 or> 14.0 mmol / L in the morning;
- •Renal function: eGFR <60 mL / min ;
- •TG> 5mmol / L;
- •Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases;
- •Ischemic heart disease, heart failure, stroke or peripheral vascular disease;
- •Pregnancy and breast-feeding women;
- •Patients requiring insulin treatment;
- •Have medical history of hypoglycemia;
- •Have a clear history of allergic patients;
- •Patients addicted to alcohol and tobacco.
结局指标
主要结局
To compare treatment arms in terms of change from baseline to endpoint in HbA1c
时间窗: 12 Weeks
To observe and compare the differences in pharmacokinetic parameters with the reatment of rE-4, adding metformin to rE-4 and exenatide, To compare treatment arms in terms of change from baseline to endpoint in HbA1c
次要结局
- To compare treatment arms in terms of change from baseline to endpoint in GA(12 Weeks)
- To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose(12 Weeks)
- To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour(12 weeks)
- To compare treatment arms in terms of change from baseline to endpoint in body weight(12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take InsulinDiabetes Mellitus, Type 2NCT04233801Boehringer Ingelheim219
已完成
1 期
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01285518Pfizer84
已完成
1 期
Safety and Tolerability of Ascending Intravenous Doses of PF-05231023 In Adult Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01396187Pfizer50
进行中（未招募）
1 期
Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy SubjectsHealthyNCT05125211Zhejiang Echon Biopharm Limited91
已完成
1 期
The Safety, Tolerability and Pharmacokinetic Study of RAY1225ObeseHealthyNCT05835752Guangdong Raynovent Biotech Co., Ltd68