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This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/065 trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin aspart and neutral protamine Hagedorn insulin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin aspart | Drug | Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hypoglycemic episodes and adverse events | at 3 and 6 months and at the end of the trial |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | at 3 and 6 months and at the end of the trial | |
| 9-point blood glucose profile | at 3 and 6 months and at the end of the trial |
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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 | Zagreb | 10 000 | Croatia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Cada DJ, Levien T, Baker DE. Insulin aspart. Hospital Pharmacy 2000; 35: 1221-1229 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin NPH | Drug | Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day |
|
| Prague |
| 10034 |
| Czechia |
| Novo Nordisk Investigational Site | Prague | 12821 | Czechia |
| Novo Nordisk Investigational Site | Tel Litwinsky | 52621 | Israel |
| Novo Nordisk Investigational Site | Moscow | 117036 | Russia |
| Novo Nordisk Investigational Site | Moscow | 119435 | Russia |
| Novo Nordisk Investigational Site | Moscow | 125315 | Russia |
| Novo Nordisk Investigational Site | Moscow | 129110 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 194354 | Russia |
| Novo Nordisk Investigational Site | Ljubljana | 1000 | Slovenia |
| 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 |
|---|---|
| D061267 | Insulin Aspart |
| D007336 | Insulin, Isophane |
| 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 |
| D049528 | Insulin, Long-Acting |
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