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

CSPC Pharmaceutical Group

Status and phase: Unknown; Phase 2

Conditions: Type 2 Diabetes

Treatments: Biological: rExenatide-4

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01342042

CSPC/PRO-rE4/IIa-04

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Metformin

Active Comparator group

Treatment:

Biological: rExenatide-4

exenatide-4

Active Comparator group

Treatment:

Biological: rExenatide-4