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

Diabetes Mellitus, Type 2 Clinical Trial

— EU-TREAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662114
• Other study ID #: NN1250-4240
• Secondary ID: U1111-1170-3128
• Status: Completed
• Start date: December 8, 2015
• Est. completion date: August 12, 2016

Study information

• Verified date: April 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2302
• Est. completion date: August 12, 2016
• Est. primary completion date: August 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• 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.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
Denmark	Novo Nordisk Investigational Site	Gentofte
Germany	Novo Nordisk Investigational Site	München
Greece	Novo Nordisk Investigational Site	Athens
Italy	Novo Nordisk Investigational Site	Perugia
Switzerland	Novo Nordisk Investigational Site	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Austria,  Denmark,  Germany,  Greece,  Italy,  Switzerland, 

References & Publications (2)

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 in — View 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 — View Citation

Outcome

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

External Links

•   Clinical Trials at Novo Nordisk