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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1149-9518 | Other Identifier | WHO |
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This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin degludec/insulin aspart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Enrolled patients will be treated with Ryzodeg® under routine clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs (adverse event) | Year 0-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SADRs (Serious Adverse Drug Reactions) | Year 0-1 | |
| Severe hypoglycaemic episodes | Year 0-1 | |
| Incidence of Serious allergic reactions (systemic or localized, including injection site reactions) |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
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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 | Tokyo | 1000005 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34800283 | Derived | Katabami T, Eriksen KT, Yamamoto Y, Ishigaki Y. Long-Term Safety and Clinical Outcomes with Insulin Degludec/Insulin Aspart Treatment in Japanese Patients with Diabetes: A Real-World, Prospective, Observational Study. Adv Ther. 2022 Jan;39(1):544-561. doi: 10.1007/s12325-021-01978-2. Epub 2021 Nov 20. |
| 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 |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
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| Year 0-1 |
| Change in Glycosylated haemoglobin A1c (HbA1c) | Week 0, week 52 |