The Safety,Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM
Lead SponsorShijiazhuang Pharma Group (CSPC)
Indication/ConditionType 2 Diabetes
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.
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.
Inclusion Criteria: 18 ~ 75 years with T2DM in China; HbA1c of 7% to 13%; negative pregnancy test in females, all subjects have no family planning during the test and after the end within 3 months. Exclusion Criteria: HBsAg, HCV, HIV and syphilis test was positive; any time FBG <6.1 or> 14.0 mmol / L in the morning; Renal function: eGFR <60 mL / min ; TG> 5mmol / L; Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases; Ischemic heart disease, heart failure, stroke or peripheral vascular disease; Pregnancy and breast-feeding women; Patients requiring insulin treatment; Have medical history of hypoglycemia; Have a clear history of allergic patients; Patients addicted to alcohol and tobacco.