Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

Phase 2

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Drug: Glucagon

• Registration Number: NCT05960565
• Lead Sponsor: St. Olavs Hospital

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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

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 Timeline

• Study First Submitted: 2023-06-19
• Study Start: 2023-06-20
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucagon	Glucagon	Micro dose of glucagon is aded at the insulin injection site

Primary Outcome Measures

Name	Time	Method
Area under the glucose curve	From time 0 minutes to time 60 minutes	The area under the glucose curve (change from baseline glucose level)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology, St. Olavs Hospital; 🇳🇴 Trondheim, Norway