Clinical trial NCT01342042: The Safety,Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
Official title: The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: diabetes
rRE-4
exenatide
metformin
CSPC ZhongQi
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University People's Hospital
name: Peking University First Hospital
First posted: 2011-04-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To compare treatment arms in terms of change from baseline to endpoint in HbA1c
timeFrame: 12 Weeks
Secondary outcomes:
measure: To compare treatment arms in terms of change from baseline to endpoint in GA
timeFrame: 12 Weeks
measure: To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose
timeFrame: 12 Weeks
measure: To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour
timeFrame: 12 weeks
measure: To compare treatment arms in terms of change from baseline to endpoint in body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Cui Yi min, MD
role: STUDY_DIRECTOR
References:
citation: Wang Y, Xu B, Zhu L, Lou K, Chen Y, Zhao X, Wang Q, Xu L, Guo X, Ji L, Cui Y, Fang Y. Pharmacokinetics and Preliminary Pharmacodynamics of Single- and Multiple-dose Lyophilized Recombinant Glucagon-like Peptide-1 Receptor Agonist (rE-4) in Chinese Patients with Type 2 Diabetes Mellitus. Clin Drug Investig. 2017 Dec;37(12):1107-1115. doi: 10.1007/s40261-017-0569-1.