Type 1 DiabetesEX-HYPONCT07373236
The Effect of Endogenous GLP-1 on Glucagon Secretion in Type 1 Diabetes
A study testing exendin(9-39)amide and Saline (0.9% NaCl) in people with Type 1 Diabetes, run by Asger Lund, MD at 1 site in Denmark.
Trial summary
Type 1 diabetes is a serious and burdensome disease that carries the risk of severe complications and premature death, partly due to low blood sugar, also called hypoglycaemia. This is a constant threat, as individuals with type 1 diabetes lack the body's natural safeguard against low blood sugar: the hormone… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- exendin(9-39)amide and Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Jan 2026to 9 Apr 2026
- 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasian ethnicity
- Age between 18 and 70 years
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
- Body mass index between 19 and 30 kg/m2
- T1D duration of 2-30 years
- C-peptide negative (5 gram arginine-stimulated C-peptide ≤100 pmol/l)
- Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months
Who cannot join
- Anaemia (haemoglobin below normal range)
- Late microvascular complications except mild non-proliferative retinopathy
- Liver disease (Evaluated by alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times normal values) or a history of hepatobiliary disorder
- Kidney disease (serum creatinine above normal range)
- Treatment with any glucose-lowering drugs beside insulin
- Active or recent (within 5 years) malignant disease
- Regular tobacco smoking or use of other nicotine-containing products
- Any condition considered incompatible with participation by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of Endogenous Glucagon-like Peptide-1 on Glucagon Secretion in Type 1 Diabetes
Type 1 diabetes is a serious and burdensome disease that carries the risk of severe complications and premature death, partly due to low blood sugar, also called hypoglycaemia. This is a constant threat, as individuals with type 1 diabetes lack the body's natural safeguard against low blood sugar: the hormone glucagon, which is normally released from the pancreas.
Recent research in mice suggests that this missing safeguard may be due to an imbalance in the hormones released from different cells in the pancreas. More specifically, glucagon-like peptide-1 (GLP-1) appears to play a role in the lack of glucagon secretion. By blocking this hormone using the substance exendin(9-39)NH₂, normalization of glucagon release during low blood sugar has been observed in mice with type 1 diabetes.
The present study aims to investigate whether the same mechanism applies in humans with type 1 diabetes. If confirmed, this finding could form the basis for a novel adjunct treatment to insulin therapy and thereby potentially reduce the risk of hypoglycaemia in this patient group.
- Conditions
- Type 1 Diabetes
- Being tested
- exendin(9-39)amide, Saline (0.9% NaCl)
- Keywords
- Type 1 diabetes, GLP-1, Exendin(9-39)NH2, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exendin(9-39)amideDrug
GLP-1 antagonist
Saline (0.9% NaCl)Drug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Exendin(9-39)NH2 | Active comparator | GLP-1 antagonist Receives: Drug: exendin(9-39)amide |
| Placebo | Placebo comparator | Saline Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bsAUC Glucagon
Entire study periode
Measured: 0-135 minutes
Secondary outcomes (5)
bsAUC of Glucagon
Primary endpoint
Measured: 30-90 minutes
Total Glucose infused
Recovery phase glucose infused
Measured: 90-135 minutes
Glucose infused (entire period)
Entire glucose infused
Measured: 0-135 minutes
GLP-1
Circulating GLP-1
Measured: 0-135 minutes
Cortisol
Cortisol
Measured: 0-135 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start23 Jan 2026
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asger Lund, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373236
- Sponsor's protocol ID
- H-25032390
- Acronym
- EX-HYPO
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Endogenous Glucagon-like Peptide-1 on Glucagon Secretion in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07373236
- Acronym / sponsor ID
- EX-HYPO / H-25032390
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, GLP-1, Exendin(9-39)NH2, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Asger Lund, MDUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 28 Jan 2026 (actual)
- 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.
Type 1 diabetes is a serious and burdensome disease that carries the risk of severe complications and premature death, partly due to low blood sugar, also called hypoglycaemia. This is a constant threat, as individuals with type 1 diabetes lack the body's natural safeguard against low blood sugar: the hormone glucagon, which is normally released from the pancreas.
Recent research in mice suggests that this missing safeguard may be due to an imbalance in the hormones released from different cells in the pancreas. More specifically, glucagon-like peptide-1 (GLP-1) appears to play a role in the lack of glucagon secretion. By blocking this hormone using the substance exendin(9-39)NH₂, normalization of glucagon release during low blood sugar has been observed in mice with type 1 diabetes.
The present study aims to investigate whether the same mechanism applies in humans with type 1 diabetes. If confirmed, this finding could form the basis for a novel adjunct treatment to insulin therapy and thereby potentially reduce the risk of hypoglycaemia in this patient group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exendin(9-39)NH2 | Active comparator | Drug: exendin(9-39)amideGLP-1 antagonist |
| Placebo | Placebo comparator | Drug: Saline (0.9% NaCl)Saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Caucasian ethnicity
- Age between 18 and 70 years
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
- Body mass index between 19 and 30 kg/m2
- T1D duration of 2-30 years
Key exclusion criteria (8 listed)
- Anaemia (haemoglobin below normal range)
- Late microvascular complications except mild non-proliferative retinopathy
- Liver disease (Evaluated by alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times normal values) or a history of hepatobiliary disorder
- Kidney disease (serum creatinine above normal range)
- Treatment with any glucose-lowering drugs beside insulin
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 |
|---|---|---|
| exendin(9-39)amideGLP-1 antagonist | Drug | Exendin(9-39)NH2 |
| Saline (0.9% NaCl)Also: PlaceboPlacebo | Drug | Placebo |
Primary outcome
bsAUC Glucagon
Time frame: 0-135 minutes
Entire study periode
5 secondary outcomes
bsAUC of Glucagon
Time frame: 30-90 minutes
Total Glucose infused
Time frame: 90-135 minutes
Glucose infused (entire period)
Time frame: 0-135 minutes
GLP-1
Time frame: 0-135 minutes
Cortisol
Time frame: 0-135 minutes
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 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exendin(9-39)amide and Saline (0.9% NaCl) in people with Type 1 Diabetes, run by Asger Lund, MD 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 7 inclusion and 8 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 29 Apr 2026. 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?
bsAUC Glucagon (time frame: 0-135 minutes). 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 29 Apr 2026.