The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man

Insulin Resistance Clinical Trial

— LVKGR  

Official title:

The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02518932
• Other study ID #: VTC-G15
• Status: Recruiting
• Phase: Phase 1
• First received: June 25, 2015
• Last updated: August 7, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2015
• Source: Elahi, Dariush, PhD
• Contact: Dariush E;ahi, PhD
• Phone: 210-283-4520
• Email: dariush.elahi[@]iconplc.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.

Description:

The investigators have previously demonstrated that infusion of the pentapeptide during hyperglycemic clamps in dogs significantly increases the glucose infusion rate necessary to maintain stable hyperglycemia without any significant differences in insulin or glucagon secretion. The present study's aim is to examine whether this also occurs in humans. It may be necessary to examine a dose response curve. Specifically, in twenty healthy volunteers glucose infusion rate during the peptide infusion will be compared to the glucose infusion rate during saline administration during a 4 hour hyperglycemic clamp, in a cross over design(mg/kg/min).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI 18.5-25;

• 33-38

Exclusion Criteria:

• T2D

• T1D

• Hypoglycemic agents

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Drug:
• Last 5 amino acids of GLP-1
To examine insulinomimetic properties of LVKGR
• placebo saline

Locations

Country	Name	City	State
United States	ICON PLC	San Antonio	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Elahi, Dariush, PhD	ICON plc, Massachusetts General Hospital, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of VTC-G15 on whole body glucose metabolism in man will be assessed by comparison of amont of glucose infusion during the peptide infusion compared to amount of infusion during placebo infusion (saline) mg/kg/min.		one year	No
Secondary	THe effect of VTC-G15(A pentapeptide cleavage product of GLP-1) on whole body glucose metabolism in man.	changes in insulin or glucagon release.	one year	No