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

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

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)

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes; Diabetes Mellitus, Type 1
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Actual): 2302

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1130
    • Novo Nordisk Investigational Site
  • Wien, Austria, 1230
    • Novo Nordisk Investigational Site
• Denmark
  • Gentofte, Denmark, 2820
    • Novo Nordisk Investigational Site
• Germany
  • München, Germany, 81925
    • Novo Nordisk Investigational Site
• Greece
  • Athens, Greece, GR-11527
    • Novo Nordisk Investigational Site
• Italy
  • Perugia, Italy, 06127
    • Novo Nordisk Investigational Site
• Switzerland
  • St. Gallen, Switzerland, 9016
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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®

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General 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.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2015
• Primary Completion (Actual): August 12, 2016
• Study Completion (Actual): August 12, 2016

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: NN1250-4240; U1111-1170-3128 (Other Identifier: WHO)