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This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised.
Hypotheses:
There are a screening visit and two treatment sessions:
Session A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Aspart without glucose supply | Other | Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply |
|
| Insulin Aspart with glucose supply | Other | Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Aspart 100 IE/ml | Drug | 1.5 IE/hour/subject/visit. Each vist takes 10 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profiles of endogenous insulin and Insulin Aspart | Pharmacokinetic profiles of endogenous insulin and Insulin Aspart in type 2 diabetes melitus patients treated with continuous subcutaneous Insulin Aspart infusion by insulin pump and combined with or without intravenous supply of glucose | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic glucose profiles | Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion . | 10 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jurgita Janukonyte, MD | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Internal Diseases | Aarhus C | Central Jutland | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25785658 | Derived | Janukonyte J, Parkner T, Bruun NH, Lauritzen T, Christiansen JS, Laursen T. Interaction between exogenous insulin, endogenous insulin, and glucose in type 2 diabetes patients. Diabetes Technol Ther. 2015 May;17(5):335-42. doi: 10.1089/dia.2014.0326. Epub 2015 Mar 18. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| D004700 | Endocrine System Diseases |