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

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01342042

Collaborator

Peking University People's Hospital (Other), Peking University First Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Biological: rExenatide-4	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Metformin	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.
Active Comparator: exenatide-4	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.

Arm

Intervention/Treatment

Active Comparator: Metformin

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.

Active Comparator: exenatide-4

Biological: rExenatide-4

Outcome Measures

Primary Outcome Measures

To compare treatment arms in terms of change from baseline to endpoint in HbA1c [12 Weeks]
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

Secondary Outcome Measures

To compare treatment arms in terms of change from baseline to endpoint in GA [12 Weeks]
To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose [12 Weeks]
To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour [12 weeks]
To compare treatment arms in terms of change from baseline to endpoint in body weight [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.