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The purpose of this study is to compare the pharmacological profile of insulin administered with jet-injection with that of insulin injected with a conventional insulin pen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy low dose insulin | Experimental | 16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight. |
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| healthy high dose insulin | Experimental | 16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight. |
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| type 1 diabetes mellitus | Experimental | 16 people with type 1 diabetes mellitus. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| jet injector (SQ pen/Novopen III) | Device | The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector. |
| Measure | Description | Time Frame |
|---|---|---|
| (time to) maximal glucose infusion rate | 0-8 hours after insulin injection |
| Measure | Description | Time Frame |
|---|---|---|
| (time to) maximal insulin concentration | 0-8 hours after insulin injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cees J Tack, MD PhD | Radboud University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre | Nijmegen | P.O. Box 9101 | 6500 HB | Netherlands |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| jet injector (SQ pen/Novopen III) | Device | The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector. |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |