Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1Phase 1NCT01218633
Dose-response Study of Exendin-9,39 on Glucose Metabolism
A Phase 1 study testing saline infusion, GLP-1-9,36 infusion and Exendin-9,39 at low dose in people with Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1, run by Adrian Vella at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1
- What is being tested?
- saline infusion, GLP-1-9,36 infusion and Exendin-9,39 at low dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2012
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action.
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.
- Being tested
- saline infusion, GLP-1-9,36 infusion, Exendin-9,39 at low dose, Exendin-9,39 at high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline infusionDrug
saline infused at 30ml/hour
GLP-1-9,36 infusionDrug
infused @ 1.2pmol/kg/min
Exendin-9,39 at low doseDrug
infused at 30pmol/kg/min
Exendin-9,39 at high doseDrug
infused @ 300pmol/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Not described Receives: Drug: saline infusion |
| GLP-1-(9,36)-amide | Active comparator | Not described Receives: Drug: GLP-1-9,36 infusion |
| Exendin-9,39 @30pmol/kg/min | Active comparator | Not described Receives: Drug: Exendin-9,39 at low dose |
| Exendin-9,39 @300pmol/kg/min | Active comparator | Not described Receives: Drug: Exendin-9,39 at high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Secretion
Measured: over 360 minutes of study
Secondary outcomes (1)
glucagon secretion
Measured: over 360 minutes of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startMay 2011
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrian Vella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adrian Vella, Mayo Clinic
- Investigators
- Adrian Vella, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218633
- Sponsor's protocol ID
- 10-003435
- Status last verified
- Jan 2013
- First submitted
- 8 Oct 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action.
- ClinicalTrials.gov ID
- NCT01218633
- Acronym / sponsor ID
- 10-003435
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Adrian VellaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Oct 2010 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: saline infusion |
| GLP-1-(9,36)-amide | Active comparator | Drug: GLP-1-9,36 infusion |
| Exendin-9,39 @30pmol/kg/min | Active comparator | Drug: Exendin-9,39 at low dose |
| Exendin-9,39 @300pmol/kg/min | Active comparator | Drug: Exendin-9,39 at high dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| saline infusionsaline infused at 30ml/hour | Drug | Saline |
| GLP-1-9,36 infusioninfused @ 1.2pmol/kg/min | Drug | GLP-1-(9,36)-amide |
| Exendin-9,39 at low doseinfused at 30pmol/kg/min | Drug | Exendin-9,39 @30pmol/kg/min |
| Exendin-9,39 at high doseinfused @ 300pmol/kg/min | Drug | Exendin-9,39 @300pmol/kg/min |
Primary outcome
Insulin Secretion
Time frame: over 360 minutes of study
1 secondary outcome
glucagon secretion
Time frame: over 360 minutes of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Derived from this study: PubMed 23545708Sathananthan 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.
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.
Adrian Vella, MD principal investigator
Mayo Clinic
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 saline infusion, GLP-1-9,36 infusion and Exendin-9,39 at low dose in people with Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1, run by Adrian Vella 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?
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: finished, as of the sponsor's last update on 23 Jan 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Secretion (time frame: over 360 minutes of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01218633, which also lists 1 linked publication.
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 23 Jan 2013.