Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

June 10, 2025 updated by: St. Olavs Hospital
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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.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

Terminated

Conditions

Intervention / Treatment

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 (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7006
        • Department of Endocrinology, St. Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From time 0 minutes to time 60 minutes
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
Time Frame: Any other time span from time 0 minutes to time 180 minutes
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
Time Frame: Any time frame from time 0 minutes to time 180 minutes
The area under the insulin curve
Any time frame from time 0 minutes to time 180 minutes
Area under glucagon curve
Time Frame: Any time frame from time 0 minutes to time 180 minutes
The area under the glucagon curve
Any time frame from time 0 minutes to time 180 minutes
Pharmacokinetics of insulin
Time Frame: Start from time 0
Time to Cmax.
Start from time 0
Pharmacokinetics of glucagon
Time Frame: Start from time 0
Time to Cmax
Start from time 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2023

Primary Completion (Actual)

December 22, 2023

Study Completion (Actual)

December 22, 2023

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)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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