Clinical trial NCT05960565: Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
Official title: Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 1 Diabetes
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: One day with glucagon and one day without glucagon
Primary purpose: TREATMENT

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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.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

Eligibility criteria: 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. -

Primary outcomes:
measure: Area under the glucose curve
timeFrame: From time 0 minutes to time 60 minutes
Secondary outcomes:
measure: Area under glucose curve
timeFrame: Any other time span from time 0 minutes to time 180 minutes
measure: Area under insulin curve
timeFrame: Any time frame from time 0 minutes to time 180 minutes
measure: Area under glucagon curve
timeFrame: Any time frame from time 0 minutes to time 180 minutes
measure: Pharmacokinetics of insulin
timeFrame: Start from time 0
measure: Pharmacokinetics of glucagon
timeFrame: Start from time 0
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Endocrinology, St. Olavs Hospital
Study officials:
affiliation: St. Olav's University Hospital
name: Sven M Carlsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Am MK, Munkerud EY, Berge MH, Christiansen SC, Carlsen SM. The effect of glucagon on local subcutaneous blood flow in non-diabetic volunteers; a proof-of-concept study. Eur J Pharmacol. 2022 Jul 5;926:175045. doi: 10.1016/j.ejphar.2022.175045. Epub 2022 May 21.
citation: Teigen IA, Riaz M, Am MK, Christiansen SC, Carlsen SM. Vasodilatory effects of glucagon: A possible new approach to enhanced subcutaneous insulin absorption in artificial pancreas devices. Front Bioeng Biotechnol. 2022 Sep 21;10:986858. doi: 10.3389/fbioe.2022.986858. eCollection 2022.