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NCT Number: NCT07373236

The Effect of Endogenous GLP-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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte Hospital

Hellerup, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

exendin(9-39)amide

Drug

GLP-1 antagonist

Saline (0.9% NaCl)

Drug

Placebo

Other names: Placebo

Primary outcomes

  1. bsAUC Glucagon

    Time frame: 0-135 minutes

    Entire study periode

Secondary outcomes

  1. bsAUC of Glucagon

    Time frame: 30-90 minutes

    Primary endpoint

  2. Total Glucose infused

    Time frame: 90-135 minutes

    Recovery phase glucose infused

  3. Glucose infused (entire period)

    Time frame: 0-135 minutes

    Entire glucose infused

  4. GLP-1

    Time frame: 0-135 minutes

    Circulating GLP-1

  5. Cortisol

    Time frame: 0-135 minutes

    Cortisol

Sponsors and collaborators

Lead sponsor

Asger Lund, MD

Other

Registry information

Official study title

Examining the Effect of Endogenous Glucagon-like Peptide-1 on Glucagon Secretion in Type 1 Diabetes

Acronym: EX-HYPO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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