Type 2 DiabetesNCT00285896
GLP-1 Infusion and Long-Time Fasting
A study testing Glucagon-like-peptide-1 (7-36) amide in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion in a glucose dependent way. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Glucagon-like-peptide-1 (7-36) amide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2005to May 2007
- Phase
- Interventional
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male, age 20-50 years, BMI 20-30 kg/m2, Blood pressure < 140/90 mmHg, caucasian.
Who cannot join
- Diabetes in relatives, anaemia, any significant disease, smoking.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of pharmacology, Aarhus university and Medical department M, Aarhus University hospital
Aarhus, 8000
About this study
Official title: The Effect of 48 Hours of GLP-1 Infusion During Long-Time Fasting on Glycaemia and Counterregulatory Hormones
GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion in a glucose dependent way. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two conditions.
Read the detailed description
GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion dependent on a normal plasma glucose.It also inhibits gastric emptying and has a trophic effect on the pancreatic beta-cells. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small.The counter regulatory response to hypoglycemia has been shown to be preserved during GLP-1 infusion. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two(48 hours of fasting followed by a glucose-load)conditions in healthy men.
Also the effect on 24 hour blood pressure will be evaluated.
- Conditions
- Type 2 Diabetes
- Being tested
- Glucagon-like-peptide-1 (7-36) amide, Placebo
- Keywords
- GLP-1, fasting, hypoglycaemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Fasting, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-like-peptide-1 (7-36) amideDrug
Also called GLP-1
Continuous, subcutaneous GLP-1 at a dose of 4.8 pmol/kg/min for 51 hours
PlaceboDrug
continuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | GLP-1 Receives: Drug: Glucagon-like-peptide-1 (7-36) amide |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC)for plasma glucose, insulin, insulin secretion velocity and glucagon for the periods 0-48 hours(day 1-2) and 0-180 min (day 3). And also the lowest plasma glucose during the period 0-180 min day 3 and mean blood pressure
Measured: measured every 4 hours for 48 hours (day 1-2) and every 15-30 minutes(day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionOct 2006
- Study completionMay 2007
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 Type 2 DiabetesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Ole E. Schmitz, Professor, Principal investigator, Department of pharmacology, Aarhus universityBirgitte Brock, MD, Study director, Department of Pharmacology ,University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285896
- Sponsor's protocol ID
- 2004-0172
- Status last verified
- Jul 2008
- First submitted
- 1 Feb 2006
- Last updated
- 11 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lerche S, Soendergaard L, Rungby J, Moeller N, Holst JJ, Schmitz OE, Brock B. No increased risk of hypoglycaemic episodes during 48 h of subcutaneous glucagon-like-peptide-1 administration in fasting healthy subjects. Clin Endocrinol (Oxf). 2009 Oct;71(4):500-6. doi: 10.1111/j.1365-2265.2008.03510.x. Epub 2008 Dec 15.
PubMed 19094067
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 48 Hours of GLP-1 Infusion During Long-Time Fasting on Glycaemia and Counterregulatory Hormones
- ClinicalTrials.gov ID
- NCT00285896
- Acronym / sponsor ID
- 2004-0172
- Conditions
- Type 2 Diabetes
- Keywords
- GLP-1, fasting, hypoglycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 2 Feb 2006 (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.
GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion in a glucose dependent way. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two conditions.
Detailed description
GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion dependent on a normal plasma glucose.It also inhibits gastric emptying and has a trophic effect on the pancreatic beta-cells. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small.The counter regulatory response to hypoglycemia has been shown to be preserved during GLP-1 infusion. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two(48 hours of fasting followed by a glucose-load)conditions in healthy men.
Also the effect on 24 hour blood pressure will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Glucagon-like-peptide-1 (7-36) amideGLP-1 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male, age 20-50 years, BMI 20-30 kg/m2, Blood pressure < 140/90 mmHg, caucasian.
Key exclusion criteria (1 listed)
- Diabetes in relatives, anaemia, any significant disease, smoking.
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 |
|---|---|---|
| Glucagon-like-peptide-1 (7-36) amideAlso: GLP-1Continuous, subcutaneous GLP-1 at a dose of 4.8 pmol/kg/min for 51 hours | Drug | Active |
| Placebocontinuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours | Drug | Placebo |
Primary outcome
Area under curve (AUC)for plasma glucose, insulin, insulin secretion velocity and glucagon for the periods 0-48 hours(day 1-2) and 0-180 min (day 3). And also the lowest plasma glucose during the period 0-180 min day 3 and mean blood pressure
Time frame: measured every 4 hours for 48 hours (day 1-2) and every 15-30 minutes(day 3)
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 11 Jul 2008.
- Derived from this study: PubMed 19094067Lerche S, Soendergaard L, Rungby J, Moeller N, Holst JJ, Schmitz OE, Brock B. No increased risk of hypoglycaemic episodes during 48 h of subcutaneous glucagon-like-peptide-1 administration in fasting healthy subjects. Clin Endocrinol (Oxf). 2009 Oct;71(4):500-6. doi: 10.1111/j.1365-2265.2008.03510.x. Epub 2008 Dec 15.
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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.
Ole E. Schmitz, Professor principal investigator
Department of pharmacology, Aarhus university
Birgitte Brock, MD study director
Department of Pharmacology ,University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagon-like-peptide-1 (7-36) amide in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jul 2008. 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 Denmark. 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.
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?
Area under curve (AUC)for plasma glucose, insulin, insulin secretion velocity and glucagon for the periods 0-48 hours(day 1-2) and 0-180 min (day 3). And also the lowest plasma glucose during the period 0-180 min day 3 and mean blood pressure (time frame: measured every 4 hours for 48 hours (day 1-2) and every 15-30 minutes(day 3)). 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 NCT00285896, 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 11 Jul 2008; AzTrials last refreshed its copy on 31 Oct 2026.