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This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin aspart users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin aspart | Drug | Prescribed by the physicians as a result of normal clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of severe hypoglycaemic symptoms | Year 1 | |
| Occurrence of severe hypoglycaemic symptoms | Year 2 for patients who had an antibody titre test performed | |
| Antibody titre findings | Year 1 | |
| Antibody titre findings | Year 2 for patients who had an antibody titre test performed | |
| Adverse events | Year 1 | |
| Adverse events | Year 2 for patients who had an antibody titre test performed |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control | Year 1 | |
| Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control | Year 2 for patients who had an antibody titre test performed |
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Inclusion Criteria:
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Patients with diabetes requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)
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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 |
|---|---|---|---|---|---|---|
| Tokyo | 1000005 | Japan |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| HbA1c (glycosylated haemoglobin) | Year 1 |
| HbA1c (glycosylated haemoglobin) | Year 2 for patients who had an antibody titre test performed |
| Total dose of insulin infused subcutaneously | Year 1 |
| Total dose of insulin infused subcutaneously | Year 2 for patients who had an antibody titre test performed |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |