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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342042
First Posted: April 26, 2011
Last Update Posted: April 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Peking University People's Hospital
Peking University First Hospital
Information provided by:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
April 23, 2011
April 26, 2011
April 26, 2011
March 2011
December 2011   (Final data collection date for primary outcome measure)
To compare treatment arms in terms of change from baseline to endpoint in HbA1c [ Time Frame: 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
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 2 Diabetes
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: Metformin
    Intervention: Biological: rExenatide-4
  • Active Comparator: exenatide-4
    Intervention: Biological: rExenatide-4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
36
December 2011
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01342042
CSPC/PRO-rE4/IIa-04
Yes
Not Provided
Not Provided
CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CSPC
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
  • Peking University People's Hospital
  • Peking University First Hospital
Study Director: Cui Yi min, MD Peking University First Hospital
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP