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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
rExenatide-4
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring diabetes, rRE-4, exenatide, metformin, CSPC ZhongQi

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Metformin

exenatide-4

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2011
Last Updated
April 25, 2011
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborators
Peking University People's Hospital, Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01342042
Brief Title
The Safety,Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
Acronym
SPPS
Official Title
The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborators
Peking University People's Hospital, Peking University First Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
diabetes, rRE-4, exenatide, metformin, CSPC ZhongQi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Active Comparator
Arm Title
exenatide-4
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
rExenatide-4
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare treatment arms in terms of change from baseline to endpoint in HbA1c
Description
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 Outcome Measure Information:
Title
To compare treatment arms in terms of change from baseline to endpoint in GA
Time Frame
12 Weeks
Title
To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose
Time Frame
12 Weeks
Title
To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour
Time Frame
12 weeks
Title
To compare treatment arms in terms of change from baseline to endpoint in body weight
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cui Yi Min, MD
Phone
86-10-88325988
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cui Yi min, MD
Organizational Affiliation
Peking University First Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University First Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cui Yi Min, MD
Phone
86-10-88325988
First Name & Middle Initial & Last Name & Degree
Cui Yi Min, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28932995
Citation
Wang Y, Xu B, Zhu L, Lou K, Chen Y, Zhao X, Wang Q, Xu L, Guo X, Ji L, Cui Y, Fang Y. Pharmacokinetics and Preliminary Pharmacodynamics of Single- and Multiple-dose Lyophilized Recombinant Glucagon-like Peptide-1 Receptor Agonist (rE-4) in Chinese Patients with Type 2 Diabetes Mellitus. Clin Drug Investig. 2017 Dec;37(12):1107-1115. doi: 10.1007/s40261-017-0569-1.
Results Reference
derived

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

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