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This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30 | Experimental |
| |
| BIAsp 50 | Experimental |
| |
| BIAsp 70 | Experimental |
| |
| Insulin aspart | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum GIR value | ||
| Time to maximum GIR value | ||
| Area under the GIR 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 |
|---|---|---|---|
| Result | Heise T, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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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 |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| biphasic insulin aspart 50 | Drug | One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days |
|
| biphasic insulin aspart 70 | Drug | One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days |
|
| insulin aspart | Drug | One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days |
|
| Cmax, maximum insulin aspart concentration |
| Area under the insulin aspart concentration curve |
| tmax, the time to maximum insulin aspart concentration |
| t½, terminal half-life |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |