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This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics 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. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin curve 6-14 hours after dinner at day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin curve 6-14 hours after dinner at day 1 | ||
| Area under the serum insulin curve 0-6 hours after dinner | ||
| Area under the curve 0-24 hours |
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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 | Ă…rhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15717874 | Result | Chen JW, Lauritzen T, Christiansen JJ, Jensen LH, Clausen WH, Christiansen JS. Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double-blinded crossover study. Diabet Med. 2005 Mar;22(3):273-7. doi: 10.1111/j.1464-5491.2004.01404.x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
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| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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| biphasic insulin aspart 70 | Drug | Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods. |
|
| Serum insulin |
| Apparent t½ (apparent elimination half life) |
| Cmax, maximum concentration |
| tmax, time to reach Cmax |
| Adverse events |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |