NCT03674866
Completed
Not Applicable
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)
InterventionsInsulin degludec
DrugsInsulin degludec
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 662
- Locations
- 1
- Primary Endpoint
- Change in Glycated Haemoglobin (HbA1c)
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with diabetes
Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®).
Intervention: Insulin degludec (Drug)
Outcomes
Primary Outcomes
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measured in % point
Secondary Outcomes
- Change in percentage of patients with HbA1c below 7%(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%(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%(Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec)
- Change in the mean Fasting Plasma Glucose (FPG)(Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec)
- Insulin degludec dose(6 months after switch to insulin degludec)
- 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))
- Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)(After change to insulin degludec (0 to 6 months))
- Percentage of patients continuing insulin degludec(After change to insulin degludec (0 to 6 months))
- Reason(s) for starting insulin degludec(At time of switch to insulin degludec (week 0))
- Reason(s) for discontinuing insulin degludec(At time of discontinuing insulin degludec (0 to 6 months))
- 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)
- 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)
- Change in body weight(Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec)
Investigators
Study Sites (1)
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