Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes

NCT06854861 | Suspended Phase 1

• 2 other identifiers: MicroGlucagon22023-510408-32-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Area under the glucose consumption curve

  Area under the glucose consumption curve

  First 30 minutes

• Area under the insulin curve Area under the insulin curve

  Area under the insulin curve

  First 30 minutes

Secondary Outcomes (2)

• Area under the glucose consumption curve

  Any time frame from 0 to 4 hours

• Area under the insulin curve

  Any time frame from 0 to 4 hours

Study Arms (2)

Lyumjev

ACTIVE COMPARATOR

Lyumjev 0.1 Unit /kg body weight

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

Drug: Premixed Lyumjev

Interventions

Lyumjev 100 UNT/ML Injectable Solution DRUG

0.1 unit insulin Lyumjev /kg body weight is injected subcutaneously

Also known as: Lyumjev

Lyumjev

Premixed Lyumjev DRUG

A solution of 5 ng glucagon /Unit Lyumjev is injcetd subcutaneously. 0.1 unit insulin / kg body weight is used.

Premixed Lyumjev

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St. Olavs University Hospital

Trondheim, 7091, Norway

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sven M Carlsen, MD PhD

  St. Olav/NTNU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One day with Lyumjev and one day with premixed Lyumjev in each participant

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: April 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)