Outcome Measures: |
Primary: Change in Glycated Haemoglobin (HbA1c), measured in % point, Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec | Secondary: 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%, 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)
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Locations: |
Novo Nordisk Investigational Site, Calgary, Alberta, T2H 2G4, Canada|Novo Nordisk Investigational Site, 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, 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
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