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

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ClinicalTrials.gov Identifier: NCT02662114
Recruitment Status : Completed
First Posted : January 25, 2016
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

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)


Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Other: No treatment given

Study Design
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Study Type : Observational
Actual Enrollment : 2302 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : December 8, 2015
Actual Primary Completion Date : August 12, 2016
Actual Study Completion Date : August 12, 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Tresiba® Other: No treatment given
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
T1DM (Type 1 diabetes mellitus) and T2DM (Type 2 diabetes mellitus) patient sample treated with Tresiba® under conditions of routine care.
Criteria

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®
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662114


Locations
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Austria
Novo Nordisk Investigational Site
Wien, Austria, 1130
Novo Nordisk Investigational Site
Wien, Austria, 1230
Denmark
Novo Nordisk Investigational Site
Gentofte, Denmark, 2820
Germany
Novo Nordisk Investigational Site
München, Germany, 81925
Greece
Novo Nordisk Investigational Site
Athens, Greece, GR-11527
Italy
Novo Nordisk Investigational Site
Perugia, Italy, 06127
Switzerland
Novo Nordisk Investigational Site
St. Gallen, Switzerland, 9016
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02662114    
Other Study ID Numbers: NN1250-4240
U1111-1170-3128 ( Other Identifier: WHO )
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases