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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1203-7872 | Other Identifier | World Health Organization (WHO) |
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The purpose of this study is to collect historical data in real life conditions in a large group of people who have type 1 or type 2 diabetes and were treated with Tresiba® (insulin degludec) for at least 6 months. Data will be collected beginning 6 months before the participant started Tresiba® up to around 6 months after the participant started taking insulin degludec.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with diabetes | Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin degludec | Drug | Participants are treated with Tresiba® (insulin degludec) under conditions of routine care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | measured in % point | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec |
| Measure | Description | Time Frame |
|---|---|---|
| Change in percentage of patients with HbA1c below 7% | percentage of patients | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec |
| Change in percentage of patients with HbA1c below 7.5% |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with type 1 or type 2 diabetes mellitus whose basal insulin was switched to insulin degludec
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Calgary | Alberta | T2H 2G4 | Canada | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33932223 | Derived | Harris SB, Ajala O, Bari B, Liutkus J, Hahn J, Martyn O, Zwicker D. Evaluating the Effectiveness of Switching to Insulin Degludec from Other Basal Insulins in a Real-World Canadian Population with Type 1 or Type 2 Diabetes: The CAN-TREAT Study. Diabetes Ther. 2021 Jun;12(6):1689-1702. doi: 10.1007/s13300-021-01063-5. Epub 2021 May 1. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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percentage of patients
| Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec |
| Change in percentage of patients with HbA1c below 8.0% | percentage of patients | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec |
| Change in the mean Fasting Plasma Glucose (FPG) | measured in mmol/L | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec |
| Insulin degludec dose | measured in units/day | At switch to insulin degludec (week 0) |
| Insulin degludec dose | measured in units/day | 6 months after switch to insulin degludec |
| Change in the mean daily insulin doses (total, basal, prandial) | measured in units/day | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec |
| Change in the number of concomitant non-insulin glucose-lowering drug classes | number of concomitant non-insulin glucose-lowering drug classes | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec |
| Change in body weight | measured in kg | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec |
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe) | percentage of patients | Before change to insulin degludec (-6 to 0 months) |
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe) | percentage of patients | After change to insulin degludec (0 to 6 months) |
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) | rates of hypoglycaemic episodes | Before change to insulin degludec (-6 to 0 months) |
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) | rates of hypoglycaemic episodes | After change to insulin degludec (0 to 6 months) |
| Percentage of patients continuing insulin degludec | percentage of patients | After change to insulin degludec (0 to 6 months) |
| Reason(s) for starting insulin degludec | Reasons for starting insulin degludec (if available) will be classified as: Not at glycaemic target, Hypoglycaemia (severe / non-severe / nocturnal), Hypoglycaemia unawareness, Multiple risk factors for hypoglycaemia (elderly, intensive exercise, Chronic Kidney Disease, other), Basal insulin dose more than 80 units/day, Twice daily basal insulin dosing, Fasting blood glucose variability, Need for flexible time of dosing, Device issue, other | At time of switch to insulin degludec (week 0) |
| Reason(s) for discontinuing insulin degludec | Reasons for discontinuing insulin degludec (if applicable and available) will be classified as: Injection site reaction, Insufficient efficacy, Hypoglycaemia (severe / non-severe / nocturnal), Weight gain, Cost, Device issue, Other | At time of discontinuing insulin degludec (0 to 6 months) |
| Edmonton |
| Alberta |
| T5T 3J7 |
| Canada |
| Novo Nordisk Investigational Site | Vancouver | British Columbia | V6J 4Y3 | Canada |
| Novo Nordisk Investigational Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Novo Nordisk Investigational Site | Shubenacadie | Nova Scotia | B2T 1A4 | Canada |
| Novo Nordisk Investigational Site | Sydney | Nova Scotia | B1P 1P3 | Canada |
| Novo Nordisk Investigational Site | Ajax | Ontario | L1Z 0M1 | Canada |
| Novo Nordisk Investigational Site | Brampton | Ontario | L6S 0C6 | Canada |
| Novo Nordisk Investigational Site | Cambridge | Ontario | N1R 7L6 | Canada |
| Novo Nordisk Investigational Site | Concord | Ontario | L4K 4M2 | Canada |
| Novo Nordisk Investigational Site | Etobicoke | Ontario | M9R 4E1 | Canada |
| Novo Nordisk Investigational Site | Guelph | Ontario | N1H 3R3 | Canada |
| Novo Nordisk Investigational Site | London | Ontario | N6A 4V2 | Canada |
| Novo Nordisk Investigational Site | London | Ontario | N6G 2M1 | Canada |
| Novo Nordisk Investigational Site | Markham | Ontario | L3P 7P2 | Canada |
| Novo Nordisk Investigational Site | Markham | Ontario | L3S 0A2 | Canada |
| Novo Nordisk Investigational Site | Nepean | Ontario | K2J 0V2 | Canada |
| Novo Nordisk Investigational Site | Oakville | Ontario | L6M 1M1 | Canada |
| Novo Nordisk Investigational Site | Orillia | Ontario | L3V 2Z6 | Canada |
| Novo Nordisk Investigational Site | Scarborough Village | Ontario | M1E 5E9 | Canada |
| Novo Nordisk Investigational Site | Smiths Falls | Ontario | K7A 4W8 | Canada |
| Novo Nordisk Investigational Site | Tecumseh | Ontario | N8N 4M7 | Canada |
| Novo Nordisk Investigational Site | Toronto | Ontario | M4G 3E8 | Canada |
| Novo Nordisk Investigational Site | Toronto | Ontario | M6G 1M2 | Canada |
| Novo Nordisk Investigational Site | Gatineau | Quebec | J8Y 0A7 | Canada |
| Novo Nordisk Investigational Site | Laval | Quebec | H7T 2P5 | Canada |
| Novo Nordisk Investigational Site | Montreal | Quebec | H2K 1H2 | Canada |
| Novo Nordisk Investigational Site | Montreal | Quebec | H4A 2C6 | Canada |
| Novo Nordisk Investigational Site | Montreal | Quebec | H4A 3T2 | Canada |
| Novo Nordisk Investigational Site | Montreal | Quebec | H4T 1Z9 | Canada |
| Novo Nordisk Investigational Site | Pierrefonds | Quebec | H8Z 1W5 | Canada |
| Novo Nordisk Investigational Site | Terrebonne | Quebec | J6X 4P7 | Canada |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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