NCT02518932

Brief Summary

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

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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

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, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

June 25, 2015

Last Update Submit

August 7, 2015

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • THe effect of VTC-G15(A pentapeptide cleavage product of GLP-1) on whole body glucose metabolism in man.

    one year

Study Arms (2)

Drug GLP-1 (32-36) Amide

EXPERIMENTAL

To examine insulinomemtic of the last 5 amino acids of GLP-1 from 60-180 min during a 4 hour hyperglycemic clamp

Drug: Last 5 amino acids of GLP-1

Placebo

PLACEBO COMPARATOR

To examine the effect of saline on glucose uptake

Drug: placebo saline

Interventions

Last 5 amino acids of GLP-1DRUG

To examine insulinomimetic properties of LVKGR

Also known as: VTC-G15; LVKGR
Drug GLP-1 (32-36) Amide
placebo salineDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • BMI 18.5-25;

You may not qualify if:

  • T2D
  • T1D
  • Hypoglycemic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON PLC

San Antonio, Texas, 78209, United States

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dariush Elahi, PhD

    ICON plc, 8307 Gault Lane, San Antonio TX 78209

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dariush E;ahi, PhD

CONTACT

210-283-4520dariush.elahi@iconplc.com

Dennis A Ruff, MD

CONTACT

210-283-4572dennis.ruff@iconplc.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

August 10, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 10, 2015

Record last verified: 2015-08

Locations

US(1)