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Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

S

St. Olavs Hospital

Status and phase

Terminated
Phase 2

Conditions

Type 1 Diabetes

Treatments

Drug: Glucagon

Study type

Interventional

Funder types

Other

Identifiers

NCT05960565
EU CT 2022-502455-57-01

Details and patient eligibility

About

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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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. -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

9 participants in 2 patient groups

Glucagon
Experimental group
Description:
Micro dose of glucagon is aded at the insulin injection site
Treatment:
Drug: Glucagon
Control
No Intervention group
Description:
Insulin injected without any glucagon

Trial contacts and locations

1

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Central trial contact

Sven M Carlsen, MD, PhD; Anne Hildur Henriksen, MD

Data sourced from clinicaltrials.gov

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