Insulin ResistancePhase 1LVKGRNCT02518932
The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man
A Phase 1 study testing Last 5 amino acids of GLP-1 in people with Insulin Resistance, run by Elahi, Dariush, PhD at 1 site in United States.
Trial summary
To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Last 5 amino acids of GLP-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18.5-25;
- 33-38
Who cannot join
- T2D
- T1D
- Hypoglycemic agents
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
ICON PLC
San Antonio, Texas, 78209
Rita Flusche, 210-283-4123, Rita.flusche@iconplc.com
About this study
To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.
Read the detailed 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).
- Conditions
- Insulin Resistance
- Being tested
- Last 5 amino acids of GLP-1, placebo saline
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Last 5 amino acids of GLP-1Drug
Also called VTC-G15; LVKGR
To examine insulinomimetic properties of LVKGR
placebo salineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Last 5 amino acids of GLP-1 |
| Placebo | Placebo comparator | To examine the effect of saline on glucose uptake Receives: Drug: placebo saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elahi, Dariush, PhD
- Collaborators
- ICON plc, Massachusetts General Hospital, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dariush Elahi, PhD, Principal investigator, ICON plc, 8307 Gault Lane, San Antonio TX 78209
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518932
- Sponsor's protocol ID
- VTC-G15
- Acronym
- LVKGR
- Status last verified
- Aug 2015
- First submitted
- 25 Jun 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man
- ClinicalTrials.gov ID
- NCT02518932
- Acronym / sponsor ID
- LVKGR / VTC-G15
- Conditions
- Insulin Resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Elahi, Dariush, PhD
- Collaborators
- ICON plc, Massachusetts General Hospital, National Institute on Aging (NIA)
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.
Detailed 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug GLP-1 (32-36) Amide | Experimental | Drug: Last 5 amino acids of GLP-1To examine insulinomemtic of the last 5 amino acids of GLP-1 from 60-180 min during a 4 hour hyperglycemic clamp |
| Placebo | Placebo comparator | Drug: placebo salineTo examine the effect of saline on glucose uptake |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 18.5-25;
- 33-38
Key exclusion criteria (3 listed)
- T2D
- T1D
- Hypoglycemic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Last 5 amino acids of GLP-1Also: VTC-G15; LVKGRTo examine insulinomimetic properties of LVKGR | Drug | Drug GLP-1 (32-36) Amide |
| placebo saline | Drug | Placebo |
Primary outcome
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.
Time frame: one year
1 secondary outcome
THe effect of VTC-G15(A pentapeptide cleavage product of GLP-1) on whole body glucose metabolism in man.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dariush Elahi, PhD principal investigator
ICON plc, 8307 Gault Lane, San Antonio TX 78209
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Last 5 amino acids of GLP-1 in people with Insulin Resistance, run by Elahi, Dariush, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dariush E;ahi, PhD (210-283-4520, dariush.elahi@iconplc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.