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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1170-3128 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus.
EU-TREAT (EUropean TREsiba AudiT)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tresiba® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | Information will be collected from the medical records (paper/electronic) of each patient at several outpatient clinics to describe the two periods of medical history: before and after the initiation date of Tresiba®. For each patient, data will be collected, to describe a minimum of 6 months to a maximum of 12 months in each period; thus, the study will collect information on 12 to 24 months of medical history for each patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c after switch to Tresiba® | Month 0, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c after switch to Tresiba® | Month 0, Month 12 | |
| Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba® | Month 0, Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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T1DM (Type 1 diabetes mellitus) and T2DM (Type 2 diabetes mellitus) patient sample treated with Tresiba® under conditions of routine care.
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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 | Vienna | 1130 | Austria | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29106039 | Result | Siegmund T, Tentolouris N, Knudsen ST, Lapolla A, Prager R, Phan TM, Wolden ML, Schultes B; EU-TREAT study group. A European, multicentre, retrospective, non-interventional study (EU-TREAT) of the effectiveness of insulin degludec after switching basal insulin in a population with type 1 or type 2 diabetes. Diabetes Obes Metab. 2018 Mar;20(3):689-697. doi: 10.1111/dom.13149. Epub 2017 Nov 21. | |
| 30879256 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba® | Month 0, Month 12 |
| Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba® | Month 0, Month 6 |
| Change in the mean FPG level after switch to Tresiba® | Month 0, Month 12 |
| Tresiba® starting dose at switch and doses | At 6 months |
| Tresiba® starting dose at switch and doses | At 12 months |
| Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® | Month 0, Month 6 |
| Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® | Month 0, Month 12 |
| Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 6 |
| Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 6 |
| Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 12 |
| Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 12 |
| Change in body weight (kg) after switch to Tresiba® | Month 0, Month 6 |
| Change in body weight (kg) after switch to Tresiba® | Month 0, Month 12 |
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® | -6 to 0 months ie 6 months before switch to Tresiba® |
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® | 0 to +6 months |
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® | -12 to 0 months ie 12 months before switch to Tresiba® |
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® | 0 to +12 months |
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) | -6 to 0 months ie 6 months before switch to Tresiba® |
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) | 0 to +6 months |
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) | -12 to 0 months ie 12 months before switch to Tresiba® |
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) | 0 to +12 months |
| Change in the number of ER (Emergency Room) visits related to hypoglycaemia after switch to Tresiba® | -6 to 0 months ie 6 months before switch to Tresiba® |
| Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® | 0 to +6 months |
| Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® | -12 to 0 months ie 12 months before switch to Tresiba® |
| Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® | 0 to +12 months |
| Change in the number of HCP (Healthcare professional(s)) visits related to hypoglycaemia after switch to Tresiba® | -6 to 0 months (ie 6 months before switch to Tresiba®) |
| Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® | 0 to +6 months |
| Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® | -12 to 0 months ie 12 months before switch to Tresiba® |
| Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® | 0 to +12 months |
| Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® | -6 to 0 months ie 6 months before switch to Tresiba® |
| Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® | 0 to +6 months |
| Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® | -12 to 0 months ie 12 months before switch to Tresiba® |
| Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® | 0 to +12 months |
| Percentage of patients continuing Tresiba® post-switch | At 6 months |
| Percentage of patients continuing Tresiba® post-switch | At 12 months |
| Reason(s) for starting Tresiba®, if available | Month 0, Month 12 |
| Reason(s) for discontinuing Tresiba®, if applicable and available | Month 0, Month 12 |
| Vienna |
| 1230 |
| Austria |
| Novo Nordisk Investigational Site | Gentofte Municipality | 2820 | Denmark |
| Novo Nordisk Investigational Site | München | 81925 | Germany |
| Novo Nordisk Investigational Site | Athens | GR-11527 | Greece |
| Novo Nordisk Investigational Site | Perugia | 06127 | Italy |
| Novo Nordisk Investigational Site | Sankt Gallen | 9016 | Switzerland |
| Result |
| Tentolouris N, Knudsen ST, Lapolla A, Wolden ML, Haldrup S, Schultes B. Switching "Real-World" Diabetes Patients to Degludec from Other Basal Insulins Provides Different Clinical Benefits According to Their Baseline Glycemic Control. Adv Ther. 2019 May;36(5):1201-1210. doi: 10.1007/s12325-019-00916-7. Epub 2019 Mar 16. |
| 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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