Type 1 DiabetesGLOXY-2NCT06881459
The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes
A study testing Oxytocin in people with Type 1 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Investigating the effect of oxytocin on pancreatic endocrine functions by determining glucagon secretion during hypoglycemia in participants with type 1 diabetes. 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?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Mar 2025to 1 Sep 2025
- 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
- Body mass index from 19 to 30 kg/m2
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
- T1D duration of 3-30 years
- C-peptide negative (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)
- Liver disease (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)
- Kidney disease (serum creatinine above normal range)
- Late microvascular complications except mild non-proliferative retinopathy
- Regular tobacco smoking or use of other nicotine-containing products
- Long QTc on electrocardiogram (ECG) at screening (≥0.45 seconds)
Show all 9Show fewer
- Pituitary gland disease
- Treatment with any glucose-lowering drugs besides insulin
- Any ongoing medication or physical or psychological condition that the investigator feels would interfere with trial participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, 2900
About this study
Investigating the effect of oxytocin on pancreatic endocrine functions by determining glucagon secretion during hypoglycemia in participants with type 1 diabetes.
Read the detailed description
Glucagonotropic effects of oxytocin will be examined in 16 participants with type 1 diabetes, during a hypoglycaemic clamp with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomised, double-blinded design. This will determine the effect of oxytocin on the glucagon response to hypoglycemia. Additional changes in plasma/serum concentrations of insulin, C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP) and glucagon-like peptide 1 (GLP-1) will be assessed.
- Conditions
- Type 1 Diabetes
- Being tested
- Placebo, Oxytocin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Saline
OxytocinDrug
Oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Infusion of placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| Infusion of oxytocin | Experimental | Infusion of oxytocin Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon secretion
Glucagon secretion, measured as the difference in plasma glucagon response to hypoglycaemia (as assessed by baseline subtracted area under curve (bsAUC)) during the hypoglycaemic clamp, between study days with oxytocin and with placebo
Measured: From time 30 to time 90 minutes
Secondary outcomes (11)
Glucagon during recovery
measured as difference in glucagon bsAUC in the recovery phase
Measured: From time 90 minutes to time 135 minutes
Glucagon during the entire period
measured as difference in glucagon bsAUC in the intire period
Measured: From time 0 minutes to time 135 minutes
Glucose infusion
measured as the total amount of glucose infused
Measured: From time 0 minutes to time 135 minutes
Insulin
measured as the difference in circulating levels of insulin between study days
Measured: From time 0 minutes to time 135 minutes
c-peptide
measured as the difference in circulating levels of c-peptide between study days
Measured: From time 0 minutes to time 135 minutes
Epinephrine
measured as the difference in circulating levels of epinephrine between study days
Measured: From time 0 minutes to time 135 minutes
Norepinephrine
measured as the difference in circulating levels of norepinephrine between study days
Measured: From time 0 minutes to time 135 minutes
Cortisol
measured as the difference in circulating levels of cortisol between study days
Measured: From time 0 minutes to time 135 minutes
Cross-linked C-telopeptide of type I collagen( CTX)
measured as the difference in circulating levels of CTX between study days
Measured: From time 0 minutes to time 135 minutes
Procollagen type I N-terminal propeptide (P1NP)
measured as the difference in circulating levels of P1NP between study days
Measured: From time 0 minutes to time 135 minutes
Growth Hormone (GH)
measured as the difference in circulating levels of GH between study days
Measured: From time 0 minutes to time 135 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start25 Mar 2025
- Primary completion18 Jul 2025
- Study completion1 Sep 2025
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
- Model description
- Randomized, double-blinded, single-arm study. Each participant goes through two experimental days in a randomized order, acting as their own controls
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881459
- Sponsor's protocol ID
- GLOXY-2
- Other IDs
- H-24080204
- Acronym
- GLOXY-2
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 9 Sep 2025
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06881459
- Acronym / sponsor ID
- GLOXY-2 / GLOXY-2
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 18 Mar 2025 (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.
Investigating the effect of oxytocin on pancreatic endocrine functions by determining glucagon secretion during hypoglycemia in participants with type 1 diabetes.
Detailed description
Glucagonotropic effects of oxytocin will be examined in 16 participants with type 1 diabetes, during a hypoglycaemic clamp with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomised, double-blinded design. This will determine the effect of oxytocin on the glucagon response to hypoglycemia. Additional changes in plasma/serum concentrations of insulin, C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP) and glucagon-like peptide 1 (GLP-1) will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, single-arm study. Each participant goes through two experimental days in a randomized order, acting as their own controls
| Arm | Type | Receives |
|---|---|---|
| Infusion of placebo | Placebo comparator | Other: PlaceboPlacebo |
| Infusion of oxytocin | Experimental | Drug: OxytocinInfusion of oxytocin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index from 19 to 30 kg/m2
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
- T1D duration of 3-30 years
- C-peptide negative (stimulated C-peptide ≤ 100 pmol/l)
- Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months
Key exclusion criteria (9 listed)
- Anaemia (haemoglobin below normal range)
- Liver disease (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)
- Kidney disease (serum creatinine above normal range)
- Late microvascular complications except mild non-proliferative retinopathy
- Regular tobacco smoking or use of other nicotine-containing products
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 |
|---|---|---|
| PlaceboSaline | Other | Infusion of placebo |
| OxytocinOxytocin | Drug | Infusion of oxytocin |
Primary outcome
Glucagon secretion
Time frame: From time 30 to time 90 minutes
Glucagon secretion, measured as the difference in plasma glucagon response to hypoglycaemia (as assessed by baseline subtracted area under curve (bsAUC)) during the hypoglycaemic clamp, between study days with oxytocin and with placebo
11 secondary outcomes
Glucagon during recovery
Time frame: From time 90 minutes to time 135 minutes
Glucagon during the entire period
Time frame: From time 0 minutes to time 135 minutes
Glucose infusion
Time frame: From time 0 minutes to time 135 minutes
Insulin
Time frame: From time 0 minutes to time 135 minutes
c-peptide
Time frame: From time 0 minutes to time 135 minutes
Epinephrine
Time frame: From time 0 minutes to time 135 minutes
Norepinephrine
Time frame: From time 0 minutes to time 135 minutes
Cortisol
Time frame: From time 0 minutes to time 135 minutes
Cross-linked C-telopeptide of type I collagen( CTX)
Time frame: From time 0 minutes to time 135 minutes
Procollagen type I N-terminal propeptide (P1NP)
Time frame: From time 0 minutes to time 135 minutes
Growth Hormone (GH)
Time frame: From time 0 minutes to time 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 9 Sep 2025.
- 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 Oxytocin in people with Type 1 Diabetes, run by University Hospital, Gentofte, Copenhagen 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 5 inclusion and 9 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 9 Sep 2025. 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?
Glucagon secretion (time frame: From time 30 to time 90 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 9 Sep 2025.