CAN-TREAT: A Canadian Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with diabetes Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®). |
Drug: Insulin degludec
Participants are treated with Tresiba® (insulin degludec) under conditions of routine care.
|
Outcome Measures
Primary Outcome Measures
- Change in Glycated Haemoglobin (HbA1c) [Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec]
measured in % point
Secondary Outcome Measures
- Change in percentage of patients with HbA1c below 7% [Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec]
percentage of patients
- Change in percentage of patients with HbA1c below 7.5% [Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec]
percentage of patients
- Change in percentage of patients with HbA1c below 8.0% [Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec]
percentage of patients
- Change in the mean Fasting Plasma Glucose (FPG) [Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec]
measured in mmol/L
- Insulin degludec dose [At switch to insulin degludec (week 0)]
measured in units/day
- Insulin degludec dose [6 months after switch to insulin degludec]
measured in units/day
- Change in the mean daily insulin doses (total, basal, prandial) [Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec]
measured in units/day
- Change in the number of concomitant non-insulin glucose-lowering drug classes [Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec]
number of concomitant non-insulin glucose-lowering drug classes
- Change in body weight [Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec]
measured in kg
- Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe) [Before change to insulin degludec (-6 to 0 months)]
percentage of patients
- Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe) [After change to insulin degludec (0 to 6 months)]
percentage of patients
- Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) [Before change to insulin degludec (-6 to 0 months)]
rates of hypoglycaemic episodes
- Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) [After change to insulin degludec (0 to 6 months)]
rates of hypoglycaemic episodes
- Percentage of patients continuing insulin degludec [After change to insulin degludec (0 to 6 months)]
percentage of patients
- Reason(s) for starting insulin degludec [At time of switch to insulin degludec (week 0)]
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
- Reason(s) for discontinuing insulin degludec [At time of discontinuing insulin degludec (0 to 6 months)]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient
-
Male or female age greater than or equal to 18 years at the time of insulin degludec initiation
-
Type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus patients
-
Switched to insulin degludec (± prandial insulin) after any basal insulin (± prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with insulin degludec at the time of patient selection
-
Previously treated with any basal insulin (± prandial insulin) for at least 6 months prior to switching to insulin degludec
-
At least one documented medical visit in the first 6 months (closest value in 3 to 9 months window) after insulin degludec initiation
-
Minimum available data at the time of insulin degludec initiation: age, type of diabetes, HbA1c, duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site for at least 1 year, and an estimated glomerular filtration rate (eGFR) value in the last 12 ±6 months (full data period)
Exclusion Criteria:
-
Previous participation in this study. Participation is defined as having signed the Informed Consent in this study
-
Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Calgary | Alberta | Canada | T2H 2G4 |
| 2 | Novo Nordisk Investigational Site | Edmonton | Alberta | Canada | T5T 3J7 |
| 3 | Novo Nordisk Investigational Site | Vancouver | British Columbia | Canada | V6J 4Y3 |
| 4 | Novo Nordisk Investigational Site | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 5 | Novo Nordisk Investigational Site | Shubenacadie | Nova Scotia | Canada | B2T 1A4 |
| 6 | Novo Nordisk Investigational Site | Sydney | Nova Scotia | Canada | B1P 1P3 |
| 7 | Novo Nordisk Investigational Site | Ajax | Ontario | Canada | L1Z 0M1 |
| 8 | Novo Nordisk Investigational Site | Brampton | Ontario | Canada | L6S 0C6 |
| 9 | Novo Nordisk Investigational Site | Cambridge | Ontario | Canada | N1R 7L6 |
| 10 | Novo Nordisk Investigational Site | Concord | Ontario | Canada | L4K 4M2 |
| 11 | Novo Nordisk Investigational Site | Etobicoke | Ontario | Canada | M9R 4E1 |
| 12 | Novo Nordisk Investigational Site | Guelph | Ontario | Canada | N1H 3R3 |
| 13 | Novo Nordisk Investigational Site | London | Ontario | Canada | N6A 4V2 |
| 14 | Novo Nordisk Investigational Site | London | Ontario | Canada | N6G 2M1 |
| 15 | Novo Nordisk Investigational Site | Markham | Ontario | Canada | L3P 7P2 |
| 16 | Novo Nordisk Investigational Site | Markham | Ontario | Canada | L3S 0A2 |
| 17 | Novo Nordisk Investigational Site | Nepean | Ontario | Canada | K2J 0V2 |
| 18 | Novo Nordisk Investigational Site | Oakville | Ontario | Canada | L6M 1M1 |
| 19 | Novo Nordisk Investigational Site | Orillia | Ontario | Canada | L3V 2Z6 |
| 20 | Novo Nordisk Investigational Site | Scarborough | Ontario | Canada | M1E 5E9 |
| 21 | Novo Nordisk Investigational Site | Smiths Falls | Ontario | Canada | K7A 4W8 |
| 22 | Novo Nordisk Investigational Site | Tecumseh | Ontario | Canada | N8N 4M7 |
| 23 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M4G 3E8 |
| 24 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M6G 1M2 |
| 25 | Novo Nordisk Investigational Site | Gatineau | Quebec | Canada | J8Y 0A7 |
| 26 | Novo Nordisk Investigational Site | Laval | Quebec | Canada | H7T 2P5 |
| 27 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H2K 1H2 |
| 28 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H4A 2C6 |
| 29 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H4A 3T2 |
| 30 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H4T 1Z9 |
| 31 | Novo Nordisk Investigational Site | Pierrefonds | Quebec | Canada | H8Z 1W5 |
| 32 | Novo Nordisk Investigational Site | Terrebonne | Quebec | Canada | J6X 4P7 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN1250-4396
- U1111-1203-7872