Type 1 DiabetesPhase 1/2MicroGlucag2NCT06854861
Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes
A Phase 1/2 study testing Lyumjev 100 UNT/ML Injectable Solution and Premixed Lyumjev in people with Type 1 Diabetes, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
We will investigate if Lyumjev premixed with nanogram amounts of glucagon speed up the absorption of insulin and the effect on whole body glucose consumption compared to native lyumjev in patients with type 1 diabetes. 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?
- Lyumjev 100 UNT/ML Injectable Solution and Premixed Lyumjev
- 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
- 1 Apr 2025to 1 Jun 2026
- Phase
- Phase 1/2
- 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
- T1D for at least one year.
- Age 18 - 70 years.
- Last known HbA1c <75 mmol/mol (< 9.0%).
- Treated with an insulin pump or a hybrid artificial pancreas (AP).
Who cannot join
- Pregnant women or women trying to conceive (women will not be screened by a pregnancy test).
- Any chronic disease, including psychiatric illnesses, judged incompatible with participation in the study.
- Unfit for participation for any reason as judged by the investigators.
- Known hypersensitivity to glucagon or to any of the excipients of the drug formulations.
- Known phaeochromocytoma.
Trial locations and contacts
1 site in 1 country.
About this study
We will investigate if Lyumjev premixed with nanogram amounts of glucagon speed up the absorption of insulin and the effect on whole body glucose consumption compared to native lyumjev in patients with type 1 diabetes. To do that we will perform euglycemic clamps investigations in patients meetinng fasting in the morning on two separate days.Frequent samples for glucose and insulin measuremenst will be drawn and the day with lyumjev only will be compared to the day with premixed Lyumjev.
Read the detailed description
Rationale:
We recently published that in healthy subjects, micro-doses of glucagon significantly increase local subcutaneous (SC) blood flow. As the absorption of insulin among other factors also depend on the local subcutaneous blood flow, we hypothesised that micro-doses of glucagon at the site of SC insulin delivery enhance the absorption of insulin and speed up the effect on blood glucose levels. Recently, in anesthetized pigs we found that adding 0.1 mg of glucagon at the site of SC insulin injection enhances the insulin absorption and we have unpublished animal data confirming that micro-doses of glucagon premixed in insulin (Lyumjev®) enhances the absorption of SC injected insulin. Thus, we hypothesize that adding micro-amounts of glucagon to an insulin solution will speed up the absorption of insulin and the effect on glucose metabolism.
Objective To study if adding micro-amounts of glucagon to a fast-acting insulin (Lyumjev®) before injection speed up the absorption of and effect on glucose metabolism of SC injected insulin.
Trial design Open, prospective, controlled, single centre investigation where patients with T1D are their own controls. They will meet fasting in the morning on two separate days and receive a SC injection with insulin on both days. One of the days they will be randomised to receive an insulin solution where 5 ng glucagon per unit insulin has been added.
After 5 patients included (4 with sufficient data) there was no clear sign of enhanced insulin absorption. The study was halted until we got approvel for increasing the glucagon dose to 100 of glucagon per unit insulin and the study was restarted.
Intervention Participants are asked to fast from midnight before entering the research facility at 08 in the morning. On the morning of the study days patients will be asked to adjust the insulin infusion to have a glucose around 6.0 mmol/L when arriving at the research facility. When arriving the pump will be shut down, and
- If glucose is >6.0 mmol/L intravenous (IV) insulin will be given (guided by a physician) for up to 2 hour to stabilize glucose levels at 6.0 mmol/L.
- If glucose is <6.0 mmol/L IV glucose is given for up to 2 hours to stabilize glucose levels at 6.0 mmol/L.
An indwelling intravenous catheter is established, and glucose is measured every 5 minutes for at least 20 minutes before the injection with study insulin or glucagon/insulin solution. Another intravenous access is also established and used for continuous glucose infusion (euglycemic clamp procedure).
The dose of insulin (Lyumjev®) or glucagon/insulin (glucagon/Lyumjev®) solution (5 ng glucagon/Unit insulin before study was halted, when restarted 100 ng glucagon/Unit insulin) will be 0.1 unit of insulin per kg body weight. The same dose of insulin is used on both study days.
- Conditions
- Type 1 Diabetes
- Being tested
- Lyumjev 100 UNT/ML Injectable Solution, Premixed Lyumjev
- 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.
Lyumjev 100 UNT/ML Injectable SolutionDrug
Also called Lyumjev
0.1 unit insulin Lyumjev /kg body weight is injected subcutaneously
Premixed LyumjevDrug
A solution of 5 ng glucagon /Unit Lyumjev is injcetd subcutaneously. 0.1 unit insulin / kg body weight is used.
| Study group | Role | What they receive |
|---|---|---|
| Lyumjev | Active comparator | Lyumjev 0.1 Unit /kg body weight Receives: Drug: Lyumjev 100 UNT/ML Injectable Solution |
| Premixed Lyumjev | Experimental | Lyumjev 0.1 Unit /kg body weight. Lyumjev is premixed with 5 ng glucagon/Unit insulin Receives: Drug: Premixed Lyumjev |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the glucose consumption curve
Area under the glucose consumption curve
Measured: First 30 minutes
Area under the insulin curve Area under the insulin curve
Area under the insulin curve
Measured: First 30 minutes
Secondary outcomes (2)
Area under the glucose consumption curve
Area under the glucose consumption curve
Measured: Any time frame from 0 to 4 hours
Area under the insulin curve
Area under the insulin curve
Measured: Any time frame from 0 to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Apr 2025
- Primary completion26 Feb 2026
- Study completion1 Jun 2026
Why it stopped: The study was terminated due toa combination of: 1. At best minimal effect on insulin absorption 2. Withdrawal of funding as the patent application for using glucagon to enhance subcutaneous insulin absorption was not approved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- One day with Lyumjev and one day with premixed Lyumjev in each participant
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Sven M Carlsen, MD PhD, Principal investigator, St. Olav/NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854861
- Sponsor's protocol ID
- MicroGlucagon2
- Other IDs
- 2023-510408-32-02, 2023
- Acronym
- MicroGlucag2
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06854861
- Acronym / sponsor ID
- MicroGlucag2 / MicroGlucagon2
- Conditions
- Type 1 Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due toa combination of: 1. At best minimal effect on insulin absorption 2. Withdrawal of funding as the patent application for using glucagon to enhance subcutaneous insulin absorption was not approved.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 3 Mar 2025 (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.
We will investigate if Lyumjev premixed with nanogram amounts of glucagon speed up the absorption of insulin and the effect on whole body glucose consumption compared to native lyumjev in patients with type 1 diabetes. To do that we will perform euglycemic clamps investigations in patients meetinng fasting in the morning on two separate days.Frequent samples for glucose and insulin measuremenst will be drawn and the day with lyumjev only will be compared to the day with premixed Lyumjev.
Detailed description
Rationale:
We recently published that in healthy subjects, micro-doses of glucagon significantly increase local subcutaneous (SC) blood flow. As the absorption of insulin among other factors also depend on the local subcutaneous blood flow, we hypothesised that micro-doses of glucagon at the site of SC insulin delivery enhance the absorption of insulin and speed up the effect on blood glucose levels. Recently, in anesthetized pigs we found that adding 0.1 mg of glucagon at the site of SC insulin injection enhances the insulin absorption and we have unpublished animal data confirming that micro-doses of glucagon premixed in insulin (Lyumjev®) enhances the absorption of SC injected insulin. Thus, we hypothesize that adding micro-amounts of glucagon to an insulin solution will speed up the absorption of insulin and the effect on glucose metabolism.
Objective To study if adding micro-amounts of glucagon to a fast-acting insulin (Lyumjev®) before injection speed up the absorption of and effect on glucose metabolism of SC injected insulin.
Trial design Open, prospective, controlled, single centre investigation where patients with T1D are their own controls. They will meet fasting in the morning on two separate days and receive a SC injection with insulin on both days. One of the days they will be randomised to receive an insulin solution where 5 ng glucagon per unit insulin has been added.
After 5 patients included (4 with sufficient data) there was no clear sign of enhanced insulin absorption. The study was halted until we got approvel for increasing the glucagon dose to 100 of glucagon per unit insulin and the study was restarted.
Intervention Participants are asked to fast from midnight before entering the research facility at 08 in the morning. On the morning of the study days patients will be asked to adjust the insulin infusion to have a glucose around 6.0 mmol/L when arriving at the research facility. When arriving the pump will be shut down, and
- If glucose is >6.0 mmol/L intravenous (IV) insulin will be given (guided by a physician) for up to 2 hour to stabilize glucose levels at 6.0 mmol/L.
- If glucose is <6.0 mmol/L IV glucose is given for up to 2 hours to stabilize glucose levels at 6.0 mmol/L.
An indwelling intravenous catheter is established, and glucose is measured every 5 minutes for at least 20 minutes before the injection with study insulin or glucagon/insulin solution. Another intravenous access is also established and used for continuous glucose infusion (euglycemic clamp procedure).
The dose of insulin (Lyumjev®) or glucagon/insulin (glucagon/Lyumjev®) solution (5 ng glucagon/Unit insulin before study was halted, when restarted 100 ng glucagon/Unit insulin) will be 0.1 unit of insulin per kg body weight. The same dose of insulin is used on both study days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One day with Lyumjev and one day with premixed Lyumjev in each participant
| Arm | Type | Receives |
|---|---|---|
| Lyumjev | Active comparator | Drug: Lyumjev 100 UNT/ML Injectable SolutionLyumjev 0.1 Unit /kg body weight |
| Premixed Lyumjev | Experimental | Drug: Premixed LyumjevLyumjev 0.1 Unit /kg body weight. Lyumjev is premixed with 5 ng glucagon/Unit insulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- T1D for at least one year.
- Age 18 - 70 years.
- Last known HbA1c <75 mmol/mol (< 9.0%).
- Treated with an insulin pump or a hybrid artificial pancreas (AP).
Key exclusion criteria (5 listed)
- Pregnant women or women trying to conceive (women will not be screened by a pregnancy test).
- Any chronic disease, including psychiatric illnesses, judged incompatible with participation in the study.
- Unfit for participation for any reason as judged by the investigators.
- Known hypersensitivity to glucagon or to any of the excipients of the drug formulations.
- 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 |
|---|---|---|
| Lyumjev 100 UNT/ML Injectable SolutionAlso: Lyumjev0.1 unit insulin Lyumjev /kg body weight is injected subcutaneously | Drug | Lyumjev |
| Premixed LyumjevA solution of 5 ng glucagon /Unit Lyumjev is injcetd subcutaneously. 0.1 unit insulin / kg body weight is used. | Drug | Premixed Lyumjev |
Primary outcome
Area under the glucose consumption curve
Time frame: First 30 minutes
Area under the glucose consumption curve
Area under the insulin curve Area under the insulin curve
Time frame: First 30 minutes
Area under the insulin curve
2 secondary outcomes
Area under the glucose consumption curve
Time frame: Any time frame from 0 to 4 hours
Area under the insulin curve
Time frame: Any time frame from 0 to 4 hours
Results and safety
The study was stopped early (reason given: The study was terminated due toa combination of: 1. At best minimal effect on insulin absorption 2. Withdrawal of funding as the patent application for using glucagon to enhance subcutaneous insulin absorption was not approved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- 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/NTNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lyumjev 100 UNT/ML Injectable Solution and Premixed Lyumjev 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 4 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 19 Oct 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: The study was terminated due toa combination of: 1. At best minimal effect on insulin absorption 2. Withdrawal of funding as the patent application for using glucagon to enhance subcutaneous insulin absorption was not approved.). 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 consumption curve (time frame: First 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.