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
- Conditions
- Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT03674866
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 662
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with diabetes Insulin degludec Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®).
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 6 months after switch to insulin degludec measured in units/day
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) 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
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
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇦Terrebonne, Quebec, Canada