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

Phase 2UnknownNCT01342042

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

rExenatide-4BIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 12 Weeks

Secondary Outcomes

To compare treatment arms in terms of change from baseline to endpoint in GA

Time frame: 12 Weeks

To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose

Time frame: 12 Weeks

To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour

Time frame: 12 weeks

To compare treatment arms in terms of change from baseline to endpoint in body weight

Time frame: 12 weeks

Central Contacts

Cui Yi Min, MD

CONTACT

86-10-88325988

Data from ClinicalTrials.gov

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