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 Overview
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Brief Summary
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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.

Official Title
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A Canadian Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus CAN-TREAT (CANadian TREsiba AudiT)

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin degludec


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with diabetes<br>Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®). | Drug: Insulin degludec<br>* Participants are treated with Tresiba® (insulin degludec) under conditions of routine care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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% | 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) |