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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004965-40 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30 | Active Comparator |
| |
| BIAsp 50 | Experimental |
| |
| BIAsp 70 | Experimental |
| |
| IAsp | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum GIR value | ||
| Time to maximum GIR value | ||
| Area under the GIR-curves |
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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 |
|---|---|---|---|
| 19049377 | Result | Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008 Dec;10(6):479-85. doi: 10.1089/dia.2008.0019. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| biphasic insulin aspart 50 | Drug | A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between |
|
| biphasic insulin aspart 70 | Drug | A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between |
|
| insulin aspart | Drug | A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between |
|
| Maximum drug concentration for insulin aspart (IAsp) |
| Time to maximum IAsp concentration |
| Area under the curve of the IAsp profiles |
| Minimum drug concentration in NEFA (Nonesterified fatty acids) |
| Time to minimum plasma concentration, NEFA |
| Area under the curve of the NEFA profiles |
| Adverse events |
| Hypoglycaemic episodes |
| 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 |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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