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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of three different periods A, B and C where a constant the insulin infusion rate is given during the periods. In period B and C will the infusion start with a bolus.
It will be investigated if a steady state of insulin will be obtained faster in period B and C then A.
A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of three different periods A, B and C where a constant the insulin infusion rate is given during the periods. Each period will last 12 hours and blood will be drawn to measure absorbed Insulin Aspart. During period A will a constant the infusion rate of insulin be given. In period B and C will there at the start of the constant infusion rate be given a bolus. The bolus in period C is calculated on the basis of the results in period B, therefore will all participants experience period C last where as period A and B is randomized cross-over. Period C is written in the protocol as optional and it is evaluated after period A and B if period C will be performed.
The hypothesis is that steady state of insulin will be obtained faster in period B and C than A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, CSII without bolus | Other | Period A: A constant subcutaneous infusion rate of insulin aspart (0.5 U/hr) is given for 8 hours. Following 3 hours of blood sampling. |
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| B; CSII with bolus | Other | Period B: A constant subcutaneous infusion of insulin aspart (0.5 U/hr) is given for 8 hours and upon start a s.c.bolus (1.4 U)of insulin aspart is given. Hereafter follows 3 hours of blood sampling. |
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| C; CSII with bolus, optional | Other | A constant subcutaneous insulin aspart infusion is given for 8 hours and upon start a bolus of insulin aspart is given. The bolus in arm C is of a different size then arm B. After the 8 hours of constant infusion follows 3 hours of blood sampling. Period C are optional and it is evaluated if it will be conducted after period A and B has been performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Aspart | Drug | A; CSII without bolus: 8 hours of constant insulin infusion. B; CSII with bolus: 8 hours of a constant insulin infusion starting with a s.c. bolus. C; CSII with bolus, optional: 8 hours of a constant insulin infusion starting with a different bolus than period B. This period is optional and it will be evaluated after period A and B if period C is conducted. |
| Measure | Description | Time Frame |
|---|---|---|
| Absorbed Insulin Aspart | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Sandahl Christiansen, Prof. Dr.Med | Aarhus University Hospital, department of Endocrinology and Diabetes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, department of Endocrinology and Diabetes | Aarhus C | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |