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

Type 2 Diabetes Clinical Trial

— SPPS  

Official title:

The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01342042
• Other study ID #: CSPC/PRO-rE4/IIa-04
• Status: Recruiting
• Phase: Phase 2
• First received: April 23, 2011
• Last updated: April 25, 2011
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2011
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: Cui Yi Min, MD
• Phone: 86-10-88325988
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Biological:
• rExenatide-4
This protein of 39 amino acids has been isolated from the venom of the lizard Heloderma suspectum (Gila monster) (Eng et al, 1992). A mammalian homolog does not seem to exist (Pohl and Wank, 1998). Exendin-4 shares 53 % identity at the amino acid level with that of the mammalian hormone GLP-1 [glucagon-like peptide-1] (Chen and Drucker, 1997). Exendin-4 is encoded within a prohormone that is distinct from the prohormone encoding glucagon. Using transgenic mice expressing exendin-4, Adatia et al (2002) have shown that mammalian cells process the lizard prohormone in endocrine and nonendocrine cell types in vitro and in murine tissues in vivo.

Locations

Country	Name	City	State
China	Peking University First Hospital	Peking	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Peking University First Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare treatment arms in terms of change from baseline to endpoint in HbA1c	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	12 Weeks	No
Secondary	To compare treatment arms in terms of change from baseline to endpoint in GA		12 Weeks	No
Secondary	To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose		12 Weeks	No
Secondary	To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour		12 weeks	No
Secondary	To compare treatment arms in terms of change from baseline to endpoint in body weight		12 weeks	No