Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Glucagon

Detailed Description

People with type 1 diabetes will come fasting in the morning to the research facility on two separate days. Both days participants will have a breakfast of their own choice and their regular dose of meal insulin injected. Lyumjev will be used. Frequently collected blood sampled will be analysed for glucose, insulin and glucagon for 3.5 hours. The procedures will be exactly the same both days except that on one of the days they will be randomised to a small dose of glucagon that will be injected at exactly the same site as Lyumjev insulin is injected.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sven M Carlsen, MD, PhD; Phone Number: +47 91769528; Email: sven.carlsen@ntnu.no
• Study Contact Backup: Name: Anne Hildur Henriksen, MD; Email: anne.hildur.henriksen@stolav.no

Study Locations

• Norway
  • Trondheim, Norway, 7006
    • Recruiting
    • Department of Endocrinology, St. Olavs Hospital
    • Contact: Sven M Carlsen, MD, PhD; Phone Number: +47 91769528; Email: sven.carlsen@ntnu.no

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1: 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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucagon; Micro dose of glucagon is aded at the insulin injection site	Drug: Glucagon; A micro-dose of glucagon is added exactly at the same site as insulin is injected.
No Intervention: Control; Insulin injected without any glucagon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under glucose curve	The area under the glucose curve (change from baseline glucose level)	Any other time span from time 0 minutes to time 180 minutes
Area under insulin curve	The area under the insulin curve	Any time frame from time 0 minutes to time 180 minutes
Area under glucagon curve	The area under the glucagon curve	Any time frame from time 0 minutes to time 180 minutes
Pharmacokinetics of insulin	Time to Cmax.	Start from time 0
Pharmacokinetics of glucagon	Time to Cmax	Start from time 0

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Investigators: Principal Investigator: Sven M Carlsen, MD, PhD, St. Olav's University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucagon
• Other Study ID Numbers: EU CT 2022-502455-57-01

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