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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1176-6538 | Other Identifier | WHO |
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This study is conducted in Europe. The aim of the study is to investigate the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin degludec/liraglutide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/liraglutide | Drug | This is a non-interventional, chart review study and the patients are treated according to current clinical practice and local licenses upon the treating physicians' decision. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (Hemoglobin A1c) | week 0, week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Month 0, month 3, month 9, months 12 | |
| Percentage of responders for HbA1c below 7 percent (53 mmol/mol) | At 3, 6, 9 and 12 months | |
| Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include adults with T2DM. Collecting data reported in medical records of patients with T2DM who received their first prescription of Xultophy® at least 6 months prior to inclusion in this study, no matter whether Xultophy® was continued afterwards.
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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 |
|---|---|---|---|
| 29205856 | Result | Price H, Bluher M, Prager R, Phan TM, Thorsted BL, Schultes B; EXTRA study group. Use and effectiveness of a fixed-ratio combination of insulin degludec/liraglutide (IDegLira) in a real-world population with type 2 diabetes: Results from a European, multicentre, retrospective chart review study. Diabetes Obes Metab. 2018 Apr;20(4):954-962. doi: 10.1111/dom.13182. Epub 2018 Jan 11. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| At 3, 6, 9 and 12 months |
| Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes | At 3, 6, 9 and 12 months |
| Leipzig |
| 04103 |
| Germany |
| Novo Nordisk Investigational Site | Stockholm | 111 57 | Sweden |
| Novo Nordisk Investigational Site | Sankt Gallen | 9016 | Switzerland |
| Novo Nordisk Investigational Site | Stevenage | SG1 4AB | United Kingdom |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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 |
|---|---|
| C000613158 | IDegLira |
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