Type 1 DiabetesPhase 2NCT05960565
Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
A Phase 2 study testing Glucagon in people with Type 1 Diabetes, run by St. Olavs Hospital at 1 site in Norway.
Trial 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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNorway
- Study dates
- 22 Dec 2023to 22 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.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.
- Conditions
- Type 1 Diabetes
- Being tested
- Glucagon
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonDrug
A micro-dose of glucagon is added exactly at the same site as insulin is injected.
| Study group | Role | What they receive |
|---|---|---|
| Glucagon | Experimental | Micro dose of glucagon is aded at the insulin injection site Receives: Drug: Glucagon |
| Control | No intervention | Insulin injected without any glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the glucose curve
The area under the glucose curve (change from baseline glucose level)
Measured: From time 0 minutes to time 60 minutes
Secondary outcomes (5)
Area under glucose curve
The area under the glucose curve (change from baseline glucose level)
Measured: Any other time span from time 0 minutes to time 180 minutes
Area under insulin curve
The area under the insulin curve
Measured: Any time frame from time 0 minutes to time 180 minutes
Area under glucagon curve
The area under the glucagon curve
Measured: Any time frame from time 0 minutes to time 180 minutes
Pharmacokinetics of insulin
Time to Cmax.
Measured: Start from time 0
Pharmacokinetics of glucagon
Time to Cmax
Measured: Start from time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start22 Dec 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Why it stopped: No sign of the anticipated effect.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- One day with glucagon and one day without glucagon
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven M Carlsen, MD, PhD, Principal investigator, St. Olav's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960565
- Sponsor's protocol ID
- EU CT 2022-502455-57-01
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35609678Teigen 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
- ClinicalTrials.gov ID
- NCT05960565
- Acronym / sponsor ID
- EU CT 2022-502455-57-01
- Conditions
- Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No sign of the anticipated effect.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One day with glucagon and one day without glucagon
| Arm | Type | Receives |
|---|---|---|
| Glucagon | Experimental | Drug: GlucagonMicro dose of glucagon is aded at the insulin injection site |
| Control | No intervention | –Insulin injected without any glucagon |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (5 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucagonA micro-dose of glucagon is added exactly at the same site as insulin is injected. | Drug | Glucagon |
Primary outcome
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)
5 secondary outcomes
Area under glucose curve
Time frame: 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
Area under glucagon curve
Time frame: Any time frame from time 0 minutes to time 180 minutes
Pharmacokinetics of insulin
Time frame: Start from time 0
Pharmacokinetics of glucagon
Time frame: Start from time 0
Results and safety
The study was stopped early (reason given: No sign of the anticipated effect.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 35609678Am 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.
- Background: PubMed 36213069Teigen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven M Carlsen, MD, PhD principal investigator
St. Olav's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glucagon in people with Type 1 Diabetes, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No sign of the anticipated effect.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the glucose curve (time frame: From time 0 minutes to time 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05960565, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.