Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
Study Details
Study Description
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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Glucagon Micro dose of glucagon is aded at the insulin injection site |
Drug: Glucagon
A micro-dose of glucagon is added exactly at the same site as insulin is injected.
|
| No Intervention: Control Insulin injected without any glucagon |
Outcome Measures
Primary Outcome Measures
- Area under the glucose curve [From time 0 minutes to time 60 minutes]
The area under the glucose curve (change from baseline glucose level)
Secondary Outcome Measures
- Area under glucose curve [Any other time span from time 0 minutes to time 180 minutes]
The area under the glucose curve (change from baseline glucose level)
- Area under insulin curve [Any time frame from time 0 minutes to time 180 minutes]
The area under the insulin curve
- Area under glucagon curve [Any time frame from time 0 minutes to time 180 minutes]
The area under the glucagon curve
- Pharmacokinetics of insulin [Start from time 0]
Time to Cmax.
- Pharmacokinetics of glucagon [Start from time 0]
Time to Cmax
Eligibility Criteria
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:
-
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. -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Endocrinology, St. Olavs Hospital | Trondheim | Norway | 7006 |
Sponsors and Collaborators
- St. Olavs Hospital
Investigators
- Principal Investigator: Sven M Carlsen, MD, PhD, St. Olav's University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- EU CT 2022-502455-57-01