Investigating 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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This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus. EU-TREAT (EUropean TREsiba AudiT)

Official Title
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A European 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

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

Intervention / Treatment
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* Other: No treatment given


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 Age at least 18 years at the time of Tresiba® initiation T1DM or insulin-treated T2DM patients Switched to Tresiba® (with or without prandial insulin) after any basal insulin (with or without prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with Tresiba® at the time of patient selection Previously treated with any basal insulin (with or without prandial insulin) for at least 6 months prior to switching to Tresiba® At least one documented medical visit in the first 9 months after Tresiba® initiation Minimum available data at the time of Tresiba® initiation: age, type of diabetes, HbA1c (Glycated haemoglobin), duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site of at least 1 year, and an eGFR (Estimated glomerular filtration rate )value in the last 12 months Exclusion Criteria: Previous participation in this study. Participation is defined as having signed the Informed Consent Participation in a diabetes clinical trial or receipt of any investigational medicinal product up to 12 months before or any time after the initiation of Tresiba® Current participation in another non-interventional study on insulin degludec (Tresiba®) 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 |
| --- | --- |
| Tresiba®<br> | Other: No treatment given<br>* Information will be collected from the medical records (paper/electronic) of each patient at several outpatient clinics to describe the two periods of medical history: before and after the initiation date of Tresiba®. For each patient, data will be collected, to describe a minimum of 6 months to a maximum of 12 months in each period; thus, the study will collect information on 12 to 24 months of medical history for each patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c after switch to Tresiba® |  | Month 0, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c after switch to Tresiba® |  | Month 0, Month 12 | 
| Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba® |  | Month 0, Month 6 | 
| Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba® |  | Month 0, Month 12 | 
| Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba® |  | Month 0, Month 6 | 
| Change in the mean FPG level after switch to Tresiba® |  | Month 0, Month 12 | 
| Tresiba® starting dose at switch and doses |  | At 6 months | 
| Tresiba® starting dose at switch and doses |  | At 12 months | 
| Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® |  | Month 0, Month 6 | 
| Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® |  | Month 0, Month 12 | 
| Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® |  | Month 0, Month 6 | 
| Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® |  | Month 0, Month 6 | 
| Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® |  | Month 0, Month 12 | 
| Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® |  | Month 0, Month 12 | 
| Change in body weight (kg) after switch to Tresiba® |  | Month 0, Month 6 | 
| Change in body weight (kg) after switch to Tresiba® |  | Month 0, Month 12 | 
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® |  | -6 to 0 months ie 6 months before switch to Tresiba® | 
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® |  | 0 to +6 months | 
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® |  | -12 to 0 months ie 12 months before switch to Tresiba® | 
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® |  | 0 to +12 months | 
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) |  | -6 to 0 months ie 6 months before switch to Tresiba® | 
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) |  | 0 to +6 months | 
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) |  | -12 to 0 months ie 12 months before switch to Tresiba® | 
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) |  | 0 to +12 months | 
| Change in the number of ER (Emergency Room) visits related to hypoglycaemia after switch to Tresiba® |  | -6 to 0 months ie 6 months before switch to Tresiba® | 
| Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® |  | 0 to +6 months | 
| Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® |  | -12 to 0 months ie 12 months before switch to Tresiba® | 
| Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® |  | 0 to +12 months | 
| Change in the number of HCP (Healthcare professional(s)) visits related to hypoglycaemia after switch to Tresiba® |  | -6 to 0 months (ie 6 months before switch to Tresiba®) | 
| Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® |  | 0 to +6 months | 
| Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® |  | -12 to 0 months ie 12 months before switch to Tresiba® | 
| Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® |  | 0 to +12 months | 
| Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® |  | -6 to 0 months ie 6 months before switch to Tresiba® | 
| Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® |  | 0 to +6 months | 
| Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® |  | -12 to 0 months ie 12 months before switch to Tresiba® | 
| Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® |  | 0 to +12 months | 
| Percentage of patients continuing Tresiba® post-switch |  | At 6 months | 
| Percentage of patients continuing Tresiba® post-switch |  | At 12 months | 
| Reason(s) for starting Tresiba®, if available |  | Month 0, Month 12 | 
| Reason(s) for discontinuing Tresiba®, if applicable and available |  | Month 0, Month 12 |