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TerminatedNCT05960565Updated Jun 13, 2025

Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

A Phase 2 interventional study of Glucagon in Type 1 Diabetes, sponsored by St. Olavs Hospital. Terminated at 1 site in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by St. Olavs Hospital · Phase 2, Interventional, and Treatment

Why this study was terminated
No sign of the anticipated effect.
Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

Read the 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.

02

Conditions studied

03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 9 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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. -
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Glucagon

    Micro dose of glucagon is aded at the insulin injection site

    Drug: Glucagon

  • No intervention
    Control

    Insulin injected without any glucagon

Interventions

  • DrugGlucagon

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

06

What researchers measure

Primary outcomes

  1. Area under the glucose curve

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

    Time frame: From time 0 minutes to time 60 minutes

Secondary outcomes

  1. Area under glucose curve

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

    Time frame: Any other time span from time 0 minutes to time 180 minutes

  2. Area under insulin curve

    The area under the insulin curve

    Time frame: Any time frame from time 0 minutes to time 180 minutes

  3. Area under glucagon curve

    The area under the glucagon curve

    Time frame: Any time frame from time 0 minutes to time 180 minutes

  4. Pharmacokinetics of insulin

    Time to Cmax.

    Time frame: Start from time 0

  5. Pharmacokinetics of glucagon

    Time to Cmax

    Time frame: Start from time 0

07

Study locations

1 site
  • Department of Endocrinology, St. Olavs Hospital
    Trondheim, 7006, Norway
08

References and documents

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. PubMed 35609678 ↗
  • 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. PubMed 36213069 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05960565
Lead sponsor
St. Olavs Hospital
Responsible party
Sponsor
First posted
Jul 25, 2023
Start date
Dec 22, 2023
Primary completion
Dec 22, 2023
Completion
Dec 22, 2023
Last update
Jun 13, 2025

Study contacts

Sven M Carlsen, MD, PhD
principal investigator · St. Olav's University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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