Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.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

Official Title
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Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Glucagon


Participation Criteria
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Eligibility Criteria
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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: 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: One day with glucagon and one day without glucagon
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucagon<br>Micro dose of glucagon is aded at the insulin injection site | Drug: Glucagon<br>* A micro-dose of glucagon is added exactly at the same site as insulin is injected.<br>|
| No Intervention: Control<br>Insulin injected without any glucagon | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose curve | The area under the glucose curve (change from baseline glucose level) | From time 0 minutes to time 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under glucose curve | The area under the glucose curve (change from baseline glucose level) | Any other time span from time 0 minutes to time 180 minutes | 
| Area under insulin curve | The area under the insulin curve | Any time frame from time 0 minutes to time 180 minutes | 
| Area under glucagon curve | The area under the glucagon curve | Any time frame from time 0 minutes to time 180 minutes | 
| Pharmacokinetics of insulin | Time to Cmax. | Start from time 0 | 
| Pharmacokinetics of glucagon | Time to Cmax | Start from time 0 |