Clinical trial NCT02662114: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-01-25
Enrollment: 2302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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)


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®

Primary outcomes:
measure: Change in HbA1c after switch to Tresiba®
timeFrame: Month 0, Month 6
Secondary outcomes:
measure: Change in HbA1c after switch to Tresiba®
timeFrame: Month 0, Month 12
measure: Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba®
timeFrame: Month 0, Month 6
measure: Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba®
timeFrame: Month 0, Month 12
measure: Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba®
timeFrame: Month 0, Month 6
measure: Change in the mean FPG level after switch to Tresiba®
timeFrame: Month 0, Month 12
measure: Tresiba® starting dose at switch and doses
timeFrame: At 6 months
measure: Tresiba® starting dose at switch and doses
timeFrame: At 12 months
measure: Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba®
timeFrame: Month 0, Month 6
measure: Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba®
timeFrame: Month 0, Month 12
measure: Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®
timeFrame: Month 0, Month 6
measure: Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®
timeFrame: Month 0, Month 6
measure: Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®
timeFrame: Month 0, Month 12
measure: Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®
timeFrame: Month 0, Month 12
measure: Change in body weight (kg) after switch to Tresiba®
timeFrame: Month 0, Month 6
measure: Change in body weight (kg) after switch to Tresiba®
timeFrame: Month 0, Month 12
measure: Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®
timeFrame: -6 to 0 months ie 6 months before switch to Tresiba®
measure: Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®
timeFrame: 0 to +6 months
measure: Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®
timeFrame: -12 to 0 months ie 12 months before switch to Tresiba®
measure: Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®
timeFrame: 0 to +12 months
measure: Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)
timeFrame: -6 to 0 months ie 6 months before switch to Tresiba®
measure: Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)
timeFrame: 0 to +6 months
measure: Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)
timeFrame: -12 to 0 months ie 12 months before switch to Tresiba®
measure: Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)
timeFrame: 0 to +12 months
measure: Change in the number of ER (Emergency Room) visits related to hypoglycaemia after switch to Tresiba®
timeFrame: -6 to 0 months ie 6 months before switch to Tresiba®
measure: Change in the number of ER visits related to hypoglycaemia after switch to Tresiba®
timeFrame: 0 to +6 months
measure: Change in the number of ER visits related to hypoglycaemia after switch to Tresiba®
timeFrame: -12 to 0 months ie 12 months before switch to Tresiba®
measure: Change in the number of ER visits related to hypoglycaemia after switch to Tresiba®
timeFrame: 0 to +12 months
measure: Change in the number of HCP (Healthcare professional(s)) visits related to hypoglycaemia after switch to Tresiba®
timeFrame: -6 to 0 months (ie 6 months before switch to Tresiba®)
measure: Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba®
timeFrame: 0 to +6 months
measure: Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba®
timeFrame: -12 to 0 months ie 12 months before switch to Tresiba®
measure: Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba®
timeFrame: 0 to +12 months
measure: Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®
timeFrame: -6 to 0 months ie 6 months before switch to Tresiba®
measure: Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®
timeFrame: 0 to +6 months
measure: Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®
timeFrame: -12 to 0 months ie 12 months before switch to Tresiba®
measure: Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®
timeFrame: 0 to +12 months
measure: Percentage of patients continuing Tresiba® post-switch
timeFrame: At 6 months
measure: Percentage of patients continuing Tresiba® post-switch
timeFrame: At 12 months
measure: Reason(s) for starting Tresiba®, if available
timeFrame: Month 0, Month 12
measure: Reason(s) for discontinuing Tresiba®, if applicable and available
timeFrame: Month 0, Month 12
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Gentofte
country: Denmark
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Perugia
country: Italy
facility: Novo Nordisk Investigational Site
city: St. Gallen
country: Switzerland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.