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 because the information has not been verified recently.
Verified April 2011 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Peking University People's Hospital
Peking University First Hospital
Information provided by:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342042
First received: April 23, 2011
Last updated: April 25, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Type 2 Diabetes
Biological: rExenatide-4
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM

Resource links provided by NLM:


Further study details as provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:

Primary Outcome Measures:
  • To compare treatment arms in terms of change from baseline to endpoint in HbA1c [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To compare treatment arms in terms of change from baseline to endpoint in body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342042

Contacts
Contact: Cui Yi Min, MD 86-10-88325988

Locations
China, Beijing
Peking University First Hospital Recruiting
Peking, Beijing, China, 010
Contact: Cui Yi Min, MD    86-10-88325988      
Principal Investigator: Cui Yi Min, MD         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Peking University People's Hospital
Peking University First Hospital
Investigators
Study Director: Cui Yi min, MD Peking University First Hospital
  More Information

No publications provided

Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CSPC
ClinicalTrials.gov Identifier: NCT01342042     History of Changes
Other Study ID Numbers: CSPC/PRO-rE4/IIa-04
Study First Received: April 23, 2011
Last Updated: April 25, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:
diabetes
rRE-4
exenatide
metformin
CSPC ZhongQi

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014