Investigating the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus (EU-TREAT)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT02662114

U1111-1170-3128 (Other Identifier)

NN1250-4240

Details and patient eligibility

About

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)

Enrollment: 2,302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®

Trial design

2,302 participants in 1 patient group

Tresiba®

Treatment:

Other: No treatment given