NCT07373236

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

November 20, 2025

Last Update Submit

April 28, 2026

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesGLP-1Exendin(9-39)NH2Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • bsAUC Glucagon

    Entire study periode

    0-135 minutes

Secondary Outcomes (5)

  • bsAUC of Glucagon

    30-90 minutes

  • Total Glucose infused

    90-135 minutes

  • Glucose infused (entire period)

    0-135 minutes

  • GLP-1

    0-135 minutes

  • Cortisol

    0-135 minutes

Study Arms (2)

Exendin(9-39)NH2

ACTIVE COMPARATOR

GLP-1 antagonist

Drug: exendin(9-39)amide

Placebo

PLACEBO COMPARATOR

Saline

Drug: Saline (0.9% NaCl)

Interventions

exendin(9-39)amideDRUG

GLP-1 antagonist

Exendin(9-39)NH2
Saline (0.9% NaCl)DRUG

Placebo

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly biological males, only cisgender men.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital

Hellerup, 2100, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Interventions

exendin (9-39)Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor, MD, Ph.D.

Study Record Dates

First Submitted

November 20, 2025

First Posted

January 28, 2026

Study Start

January 23, 2026

Primary Completion

April 9, 2026

Study Completion

April 9, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)