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CompletedNCT01218633Updated Jan 23, 2013

Dose-response Study of Exendin-9,39 on Glucose Metabolism

A Phase 1 interventional study of saline infusion and GLP-1-9,36 infusion in Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1, sponsored by Adrian Vella. Completed at 1 site in United States. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-23.

Sponsored by Adrian Vella · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

Multiple studies have examined the effect of endogenous GLP-1 secretions by using a competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However, the presence of an effect does not necessarily imply that this effect is due to the blockade of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic concentrations of Exendin may have effects of its own. To examine the effect of Exendin on glucose metabolism the investigators propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion.

02

Conditions studied

  • Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1
03

In context

Lead sponsor

Adrian Vella is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Placebo comparator
    Saline

    Drug: saline infusion

  • Active comparator
    GLP-1-(9,36)-amide

    Drug: GLP-1-9,36 infusion

  • Active comparator
    Exendin-9,39 @30pmol/kg/min

    Drug: Exendin-9,39 at low dose

  • Active comparator
    Exendin-9,39 @300pmol/kg/min

    Drug: Exendin-9,39 at high dose

Interventions

  • Drugsaline infusion

    saline infused at 30ml/hour

  • DrugGLP-1-9,36 infusion

    infused @ 1.2pmol/kg/min

  • DrugExendin-9,39 at low dose

    infused at 30pmol/kg/min

  • DrugExendin-9,39 at high dose

    infused @ 300pmol/kg/min

06

What researchers measure

Primary outcomes

  1. Insulin Secretion

    Time frame: over 360 minutes of study

Secondary outcomes

  1. glucagon secretion

    Time frame: over 360 minutes of study

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Publications

  • Sathananthan M, Farrugia LP, Miles JM, Piccinini F, Dalla Man C, Zinsmeister AR, Cobelli C, Rizza RA, Vella A. Direct effects of exendin-(9,39) and GLP-1-(9,36)amide on insulin action, beta-cell function, and glucose metabolism in nondiabetic subjects. Diabetes. 2013 Aug;62(8):2752-6. doi: 10.2337/db13-0140. Epub 2013 Apr 1. PubMed 23545708 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Jul 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2010
First posted
Oct 11, 2010
Start
May 2011
Primary completionActual
Jul 2012
CompletionActual
Dec 2012
Last update
Jan 23, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01218633
Lead sponsor
Adrian Vella
Responsible party
Adrian Vella (Professor of Medicine, Mayo Clinic) — Sponsor-investigator
First posted
Oct 11, 2010
Start date
May 2011
Primary completion
Jul 2012
Completion
Dec 2012
Last update
Jan 23, 2013

Study contacts

Adrian Vella, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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