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

NCT ID: NCT02518932

Last Updated: 2015-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Drug GLP-1 (32-36) Amide

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

Group Type EXPERIMENTAL

Last 5 amino acids of GLP-1

Intervention Type DRUG

To examine insulinomimetic properties of LVKGR

Placebo

To examine the effect of saline on glucose uptake

Group Type PLACEBO_COMPARATOR

placebo saline

Intervention Type DRUG

Interventions

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Last 5 amino acids of GLP-1

To examine insulinomimetic properties of LVKGR

Intervention Type DRUG

placebo saline

Intervention Type DRUG

Other Intervention Names

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VTC-G15; LVKGR

Eligibility Criteria

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Inclusion Criteria

* BMI 18.5-25;
* 33-38

Exclusion Criteria

* T2D
* T1D
* Hypoglycemic agents
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ICON plc

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Elahi, Dariush, PhD

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dariush Elahi, PhD

Role: PRINCIPAL_INVESTIGATOR

ICON plc, 8307 Gault Lane, San Antonio TX 78209

Locations

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ICON PLC

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dariush E;ahi, PhD

Role: CONTACT

210-283-4520

Dennis A Ruff, MD

Role: CONTACT

210-283-4572

Facility Contacts

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Rita Flusche

Role: primary

210-283-4123

Other Identifiers

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VTC-G15

Identifier Type: -

Identifier Source: org_study_id

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