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This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment period 1 | Experimental |
| |
| Treatment period 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods |
| Measure | Description | Time Frame |
|---|---|---|
| Steady state area under the glucose infusion rate profile, 6-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| GIRmax, the maximal glucose infusion rate value | ||
| tmax, time to maximum glucose infusion rate value | ||
| area under the glucose infusion rate profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR,1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16235159 | Result | Bott S, Tusek C, Heinemann L, Friberg HH, Heise T. The pharmacokinetic and pharmacodynamic properties of biphasic insulin Aspart 70 (BIAsp 70) are significantly different from those of biphasic insulin Aspart 30 (BIAsp 30). Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):545-50. doi: 10.1055/s-2005-872852. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| biphasic insulin aspart 70 | Drug | Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods |
|
| Time to 50% of area under the glucose infusion rate profile, 0-12 hours |
| Cmax, maximum concentration |
| tmax, time to reach Cmax |
| Area under the curve |
| t½, terminal half-life |
| Adverse events |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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