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

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

Tracking Information

• First Submitted Date: December 4, 2015
• First Posted Date: January 25, 2016
• Last Update Posted Date: May 2, 2019
• Actual Study Start Date: December 8, 2015
• Actual Primary Completion Date: August 12, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 21, 2016): Change in HbA1c after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 21, 2016)

• Change in HbA1c after switch to Tresiba® [ Time Frame: 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® [ Time Frame: 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® [ Time Frame: Month 0, Month 12 ]
• Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
• Change in the mean FPG level after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
• Tresiba® starting dose at switch and doses [ Time Frame: At 6 months ]
• Tresiba® starting dose at switch and doses [ Time Frame: At 12 months ]
• Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
• Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
• Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
• Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
• Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
• Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
• Change in body weight (kg) after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
• Change in body weight (kg) after switch to Tresiba® [ Time Frame: 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® [ Time Frame: -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® [ Time Frame: 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® [ Time Frame: -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® [ Time Frame: 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) [ Time Frame: -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) [ Time Frame: 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) [ Time Frame: -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) [ Time Frame: 0 to +12 months ]
• 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® ]
• Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +6 months ]
• 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® ]
• Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +12 months ]
• 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®) ]
• Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +6 months ]
• 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® ]
• Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +12 months ]
• 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® ]
• Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +6 months ]
• 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® ]
• Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +12 months ]
• Percentage of patients continuing Tresiba® post-switch [ Time Frame: At 6 months ]
• Percentage of patients continuing Tresiba® post-switch [ Time Frame: At 12 months ]
• Reason(s) for starting Tresiba®, if available [ Time Frame: Month 0, Month 12 ]
• Reason(s) for discontinuing Tresiba®, if applicable and available [ Time Frame: Month 0, Month 12 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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)

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Diabetes
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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.

Study Groups/Cohorts

Tresiba®

Intervention: Other: No treatment given

Publications *

• Siegmund T, Tentolouris N, Knudsen ST, Lapolla A, Prager R, Phan TM, Wolden ML, Schultes B; EU-TREAT study group. A European, multicentre, retrospective, non-interventional study (EU-TREAT) of the effectiveness of insulin degludec after switching basal insulin in a population with type 1 or type 2 diabetes. Diabetes Obes Metab. 2018 Mar;20(3):689-697. doi: 10.1111/dom.13149. Epub 2017 Nov 21.
• Tentolouris N, Knudsen ST, Lapolla A, Wolden ML, Haldrup S, Schultes B. Switching "Real-World" Diabetes Patients to Degludec from Other Basal Insulins Provides Different Clinical Benefits According to Their Baseline Glycemic Control. Adv Ther. 2019 May;36(5):1201-1210. doi: 10.1007/s12325-019-00916-7. Epub 2019 Mar 16.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 28, 2016): 2302
• Original Estimated Enrollment (submitted: January 21, 2016): 2644
• Actual Study Completion Date: August 12, 2016
• Actual Primary Completion Date: August 12, 2016 (Final data collection date for primary outcome measure)

Eligibility 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®

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Denmark, Germany, Greece, Italy, Switzerland

Administrative Information

• NCT Number: NCT02662114
• Other Study ID Numbers: NN1250-4240; U1111-1170-3128 ( Other Identifier: WHO )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novo Nordisk A/S
• Study Sponsor: Novo Nordisk A/S
• Collaborators: Not Provided

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: April 2019