Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

Type 1 Diabetes Clinical Trial

Official title:

Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960565
• Other study ID #: EU CT 2022-502455-57-01
• Status: Recruiting
• Phase: Phase 2
• Start date: June 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: St. Olavs Hospital
• Contact: Sven M Carlsen, MD, PhD
• Phone: +47 91769528
• Email: sven.carlsen[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Norway	Department of Endocrinology, St. Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Area under insulin curve	The area under the insulin curve	Any time frame from time 0 minutes to time 180 minutes
Secondary	Area under glucagon curve	The area under the glucagon curve	Any time frame from time 0 minutes to time 180 minutes
Secondary	Pharmacokinetics of insulin	Time to Cmax.	Start from time 0
Secondary	Pharmacokinetics of glucagon	Time to Cmax	Start from time 0