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The Effect of Endogenous GLP-1 on Glucagon Secretion in Type 1 Diabetes (EX-HYPO) 12 Novel Treatment

Recruiting
Clinical Trial NCT07373236 (EX-HYPO) is an interventional study for Type 1 Diabetes that is recruiting. It started on January 23, 2026 with plans to enroll 12 participants. Led by Asger Lund, MD, it is expected to complete by March 31, 2026. The latest data from ClinicalTrials.gov was last updated on January 28, 2026.
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 s...

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Official Title

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

Conditions
Type 1 Diabetes
Other Study IDs
  • EX-HYPO
  • H-25032390
NCT ID Number
NCT07373236
Start Date (Actual)
2026-01-23
Last Update Posted
2026-01-28
Completion Date (Estimated)
2026-03-31
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Type 1 diabetes
GLP-1
Exendin(9-39)NH2
Hypoglycemia
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorExendin(9-39)NH2
GLP-1 antagonist
exendin(9-39)amide
GLP-1 antagonist
Placebo ComparatorPlacebo
Saline
Saline (0.9% NaCl)
Placebo
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
bsAUC Glucagon
Entire study periode
0-135 minutes
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
bsAUC of Glucagon
Primary endpoint
30-90 minutes
Total Glucose infused
Recovery phase glucose infused
90-135 minutes
Glucose infused (entire period)
Entire glucose infused
0-135 minutes
GLP-1
Circulating GLP-1
0-135 minutes
Cortisol
Cortisol
0-135 minutes
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • 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

  • 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.
Asger Lund, MD logoAsger Lund, MD
Study Responsible Party
Asger Lund, MD, Sponsor-Investigator, Associate professor, MD, Ph.D., University Hospital, Gentofte, Copenhagen
Study Central Contact
Contact: Julie Warnøe, MD, +4527282263, [email protected]
1 Study Locations in 1 Countries
Gentofte Hospital, Hellerup, 2100, Denmark
Julie Warnøe, MD, Contact, +4527282263, [email protected]
Recruiting