The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes (GLOXY-2)

Investigating the effect of oxytocin on pancreatic endocrine functions by determining glucagon secretion during hypoglycemia in participants with type 1 diabetes.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Placebo; Drug: Oxytocin

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Center for Clinical Metabolic Research, Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Infusion of placebo; Placebo	Other: Placebo; Saline
Experimental: Infusion of oxytocin	Drug: Oxytocin; Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From time 30 to time 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucagon during recovery	measured as difference in glucagon bsAUC in the recovery phase	From time 90 minutes to time 135 minutes
Glucagon during the entire period	measured as difference in glucagon bsAUC in the intire period	From time 0 minutes to time 135 minutes
Glucose infusion	measured as the total amount of glucose infused	From time 0 minutes to time 135 minutes
Insulin	measured as the difference in circulating levels of insulin between study days	From time 0 minutes to time 135 minutes
c-peptide	measured as the difference in circulating levels of c-peptide between study days	From time 0 minutes to time 135 minutes
Epinephrine	measured as the difference in circulating levels of epinephrine between study days	From time 0 minutes to time 135 minutes
Norepinephrine	measured as the difference in circulating levels of norepinephrine between study days	From time 0 minutes to time 135 minutes
Cortisol	measured as the difference in circulating levels of cortisol between study days	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	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	From time 0 minutes to time 135 minutes
Growth Hormone (GH)	measured as the difference in circulating levels of GH between study days	From time 0 minutes to time 135 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): July 18, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Substandard Drugs; Pharmaceutical Preparations; Pituitary Hormones, Posterior; Pituitary Hormones; Oxytocin; Counterfeit Drugs
• Other Study ID Numbers: GLOXY-2; H-24080204 (Other Identifier: The Danish Health Research Ethics Committee system)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No