Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

NCT05960565 | Terminated Phase 2

• 1 other identifier: EU CT 2022-502455-57-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will study the effect of microdoses of glucagon at the site of subcutaneous insulin injection. The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Area under the glucose curve

  The area under the glucose curve (change from baseline glucose level)

  From time 0 minutes to time 60 minutes

Secondary Outcomes (5)

• Area under glucose curve

  Any other time span from time 0 minutes to time 180 minutes

• Area under insulin curve

  Any time frame from time 0 minutes to time 180 minutes

• Area under glucagon curve

  Any time frame from time 0 minutes to time 180 minutes

• Pharmacokinetics of insulin

  Start from time 0

• Pharmacokinetics of glucagon

  Start from time 0

Study Arms (2)

Glucagon

EXPERIMENTAL

Micro dose of glucagon is aded at the insulin injection site

Drug: Glucagon

Control

NO INTERVENTION

Insulin injected without any glucagon

Interventions

Glucagon DRUG

A micro-dose of glucagon is added exactly at the same site as insulin is injected.

Glucagon

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Type 1 diabetes for at least 1 year. 2. Age 18 - 70 years. 3. Last known HbA1c \<86 mmol/mol. 4. Treated with continuous subcutaneous insulin infusion (CSII) by an insulin pump or multiple daily insulin injections (MDII).

You may not qualify if:

• Pregnant women or women trying to conceive.
• Any chronic disease, including psychiatric illness, judged incompatible with participation in the study.
• Unfit for participation for any reason judged by the investigators.
• Known hypersensitivity to glucagon or any of the excipients of the drug formulation.
• Known phaeochromocytoma. -

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

Department of Endocrinology, St. Olavs Hospital

Trondheim, 7006, Norway

Location

Related Publications (2)

• Am MK, Munkerud EY, Berge MH, Christiansen SC, Carlsen SM. The effect of glucagon on local subcutaneous blood flow in non-diabetic volunteers; a proof-of-concept study. Eur J Pharmacol. 2022 Jul 5;926:175045. doi: 10.1016/j.ejphar.2022.175045. Epub 2022 May 21.

  PMID: 35609678 BACKGROUND

• Teigen IA, Riaz M, Am MK, Christiansen SC, Carlsen SM. Vasodilatory effects of glucagon: A possible new approach to enhanced subcutaneous insulin absorption in artificial pancreas devices. Front Bioeng Biotechnol. 2022 Sep 21;10:986858. doi: 10.3389/fbioe.2022.986858. eCollection 2022.

  PMID: 36213069 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Sven M Carlsen, MD, PhD

  St. Olav's University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One day with glucagon and one day without glucagon

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 25, 2023
• Study Start: December 22, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)