NCT01342042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

Enrollment Period

9 months

First QC Date

April 23, 2011

Last Update Submit

April 25, 2011

Conditions

Type 2 Diabetes

Keywords

diabetesrRE-4exenatidemetforminCSPC ZhongQi

Outcome Measures

Primary Outcomes (1)

  • 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

    12 Weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

Metformin

ACTIVE COMPARATOR
Biological: rExenatide-4

exenatide-4

ACTIVE COMPARATOR
Biological: rExenatide-4

Interventions

rExenatide-4BIOLOGICAL

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.

Metforminexenatide-4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28932995DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Cui Yi min, MD

    Peking University First Hospital

    STUDY DIRECTOR

Central Study Contacts

Cui Yi Min, MD

CONTACT

86-10-88325988

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2011

First Posted

April 26, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 26, 2011

Record last verified: 2011-04

Locations

CN(1)