The Safety,Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus

Phase 2

• Conditions: Type 2 Diabetes
• Interventions: Biological: rExenatide-4

• Registration Number: NCT01342042
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-04
• Study First Submitted: 2011-04-23
• Study First Submitted QC: 2011-04-25
• Last Update Submitted: 2011-04-25
• Study First Posted: 2011-04-26
• Last Update Posted: 2011-04-26
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. 18 ~ 75 years with T2DM in China;
2. HbA1c of 7% to 13%;
3. negative pregnancy test in females, all subjects have no family planning during the test and after the end within 3 months.

Exclusion Criteria

1. HBsAg, HCV, HIV and syphilis test was positive;
2. any time FBG <6.1 or> 14.0 mmol / L in the morning;
3. Renal function: eGFR <60 mL / min ;
4. TG> 5mmol / L;
5. Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases;
6. Ischemic heart disease, heart failure, stroke or peripheral vascular disease;
7. Pregnancy and breast-feeding women;
8. Patients requiring insulin treatment;
9. Have medical history of hypoglycemia;
10. Have a clear history of allergic patients;
11. Patients addicted to alcohol and tobacco.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	rExenatide-4	-
exenatide-4	rExenatide-4	-

Primary Outcome Measures

Name	Time	Method
To compare treatment arms in terms of change from baseline to endpoint in HbA1c	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Peking, Beijing, China