Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-22

Study Completion Date

2023-12-22

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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

One day with glucagon and one day without glucagon

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glucagon

Micro dose of glucagon is aded at the insulin injection site

Group Type EXPERIMENTAL

Glucagon

Intervention Type DRUG

A micro-dose of glucagon is added exactly at the same site as insulin is injected.

Control

Insulin injected without any glucagon

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Glucagon

A micro-dose of glucagon is added exactly at the same site as insulin is injected.

Intervention Type DRUG

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

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. -

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No