Trial · Interventional

TerminatedPhase 2Registry data

Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

NCTNCT05960565Other idEU CT 2022-502455-57-01

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: No sign of the anticipated effect.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 9 participants (actual)
Sponsor: St. Olavs Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Norway
Start: 22 Dec 2023
Primary completion: 22 Dec 2023
Completion: 22 Dec 2023
First posted: 25 Jul 2023
Last update posted: 13 Jun 2025
Conditions: Type 1 Diabetes

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20232024

Ph 2
Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
NCT05960565
22 Dec 2023 to 22 Dec 2023
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

Interventions

GlucagonDrug

Arms2

Experimental
Glucagon
Micro dose of glucagon is aded at the insulin injection site
No intervention
Control
Insulin injected without any glucagon

Primary outcomes1

Outcomes the sponsor listed as primary.

Area under the glucose curve
Time frame · From time 0 minutes to time 60 minutes
Registry description
The area under the glucose curve (change from baseline glucose level)

Secondary outcomes(5)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2022

3 results

The effect of glucagon on local subcutaneous blood flow in non-diabetic volunteers; a proof-of-concept study.

Åm et al. 2022European journal of pharmacologycited by 5

PMID 35609678DOI 10.1016/j.ejphar.2022.175045PUB-35609678

CC BY3 results

Read at source See results (3)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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. -

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