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No sign of the anticipated effect.
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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 The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucagon | Experimental | Micro dose of glucagon is aded at the insulin injection site |
|
| Control | No Intervention | Insulin injected without any glucagon |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon | Drug | A micro-dose of glucagon is added exactly at the same site as insulin is injected. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose curve | The area under the glucose curve (change from baseline glucose level) | From time 0 minutes to time 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Area under insulin curve | The area under the insulin curve |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Sven M Carlsen, MD, PhD | St. Olav's University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, St. Olavs Hospital | Trondheim | 7006 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35609678 | Background | 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. | |
| 36213069 | Background | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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One day with glucagon and one day without glucagon
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| Any time frame from time 0 minutes to time 180 minutes |
| Area under glucagon curve | The area under the glucagon curve | Any time frame from time 0 minutes to time 180 minutes |
| Pharmacokinetics of insulin | Time to Cmax. | Start from time 0 |
| Pharmacokinetics of glucagon | Time to Cmax | Start from time 0 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |