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Completed

NCT Number: NCT02662114

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

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)

Completed

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

No treatment given

Other

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.

Primary outcomes

  1. Change in HbA1c after switch to Tresiba®

    Time frame: Month 0, Month 6

Secondary outcomes

  1. Change in HbA1c after switch to Tresiba®

    Time frame: Month 0, Month 12

  2. Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba®

    Time frame: Month 0, Month 6

  3. Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba®

    Time frame: Month 0, Month 12

  4. Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba®

    Time frame: Month 0, Month 6

  5. Change in the mean FPG level after switch to Tresiba®

    Time frame: Month 0, Month 12

  6. Tresiba® starting dose at switch and doses

    Time frame: At 6 months

  7. Tresiba® starting dose at switch and doses

    Time frame: At 12 months

  8. Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba®

    Time frame: Month 0, Month 6

  9. Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba®

    Time frame: Month 0, Month 12

  10. Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®

    Time frame: Month 0, Month 6

  11. Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®

    Time frame: Month 0, Month 6

  12. Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®

    Time frame: Month 0, Month 12

  13. Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®

    Time frame: Month 0, Month 12

  14. Change in body weight (kg) after switch to Tresiba®

    Time frame: Month 0, Month 6

  15. Change in body weight (kg) after switch to Tresiba®

    Time frame: Month 0, Month 12

  16. Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®

    Time frame: -6 to 0 months ie 6 months before switch to Tresiba®

  17. Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®

    Time frame: 0 to +6 months

  18. Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®

    Time frame: -12 to 0 months ie 12 months before switch to Tresiba®

  19. Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®

    Time frame: 0 to +12 months

  20. Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)

    Time frame: -6 to 0 months ie 6 months before switch to Tresiba®

  21. Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)

    Time frame: 0 to +6 months

  22. Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)

    Time frame: -12 to 0 months ie 12 months before switch to Tresiba®

  23. Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)

    Time frame: 0 to +12 months

  24. Change in the number of ER (Emergency Room) visits related to hypoglycaemia after switch to Tresiba®

    Time frame: -6 to 0 months ie 6 months before switch to Tresiba®

  25. Change in the number of ER visits related to hypoglycaemia after switch to Tresiba®

    Time frame: 0 to +6 months

  26. Change in the number of ER visits related to hypoglycaemia after switch to Tresiba®

    Time frame: -12 to 0 months ie 12 months before switch to Tresiba®

  27. Change in the number of ER visits related to hypoglycaemia after switch to Tresiba®

    Time frame: 0 to +12 months

  28. Change in the number of HCP (Healthcare professional(s)) visits related to hypoglycaemia after switch to Tresiba®

    Time frame: -6 to 0 months (ie 6 months before switch to Tresiba®)

  29. Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba®

    Time frame: 0 to +6 months

  30. Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba®

    Time frame: -12 to 0 months ie 12 months before switch to Tresiba®

  31. Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba®

    Time frame: 0 to +12 months

  32. Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®

    Time frame: -6 to 0 months ie 6 months before switch to Tresiba®

  33. Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®

    Time frame: 0 to +6 months

  34. Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®

    Time frame: -12 to 0 months ie 12 months before switch to Tresiba®

  35. Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®

    Time frame: 0 to +12 months

  36. Percentage of patients continuing Tresiba® post-switch

    Time frame: At 6 months

  37. Percentage of patients continuing Tresiba® post-switch

    Time frame: At 12 months

  38. Reason(s) for starting Tresiba®, if available

    Time frame: Month 0, Month 12

  39. Reason(s) for discontinuing Tresiba®, if applicable and available

    Time frame: Month 0, Month 12

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: EU-TREAT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2016
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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