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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1158-0248 | Other Identifier | WHO | |
| ENCEPP/SDPP/7880 | Other Identifier | EU PAS |
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This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin degludec |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Tresiba® will be prescribed by the physician under normal clinical practice conditions and will be obtained/ purchased from the chemist based on physician prescription. No treatment given. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of any hypoglycaemic episodes | End of 4 week baseline period, end of 12 month observation period |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c (glycosylated haemoglobin) | 0- 12 months | |
| Change from baseline in FPG (Fasting Plasma Glucose) | 0-12 months | |
| Change from the baseline period in the number of severe hypoglycaemic episodes |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patients aged at least 18 years of age with either T1DM or T2DM (insulin using) (clinically diagnosed) prior to visit 1, who signed an informed consent form, and whose physician plans to start Tresiba® treatment are eligible for entry in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Aarhus | 8200 | Denmark | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31397845 | Result | Fadini GP, Feher M, Hansen TK, de Valk HW, Koefoed MM, Wolden M, Zimmermann E, Jendle J. Switching to Degludec From Other Basal Insulins Is Associated With Reduced Hypoglycemia Rates: A Prospective Study. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5977-5990. doi: 10.1210/jc.2019-01021. | |
| 33011923 | Derived | Fadini GP, Giordano C, Salvi L, Nicolucci A; REFLECT Italian Study Group. Reduced Rates of Hypoglycemia in Type 1 or Type 2 Diabetes After Switching to Insulin Degludec: Results from the Italian Cohort of the ReFLeCT Study. Diabetes Ther. 2020 Dec;11(12):2909-2920. doi: 10.1007/s13300-020-00936-5. Epub 2020 Oct 3. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| 0-12 months |
| Change from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire )) | 0-12 months |
| München |
| 81925 |
| Germany |
| Novo Nordisk Investigational Site | Padova | 35122 | Italy |
| Novo Nordisk Investigational Site | Utrecht | 3508 GA | Netherlands |
| Novo Nordisk Investigational Site | Palma de Mallorca | 07015 | Spain |
| Novo Nordisk Investigational Site | Karlstad | 651 85 | Sweden |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| Novo Nordisk Investigational Site | London | SW10 9NH | United Kingdom |
| 32666165 | Derived | de Valk HW, Feher M, Hansen TK, Jendle J, Koefoed MM, Rizi EP, Zimmermann E, Fadini GP. Switching to Degludec is Associated with Reduced Hypoglycaemia, Irrespective of Definition Used or Patient Characteristics: Secondary Analysis of the ReFLeCT Prospective, Observational Study. Diabetes Ther. 2020 Sep;11(9):2159-2167. doi: 10.1007/s13300-020-00875-1. Epub 2020 Jul 14. |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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