NCT02662114|Completed

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN1250-4240U1111-1170-3128

Study Type

observational

Target

2,302

Locations

6 countries

Sites

Timeline

RegisteredJan 2016

StartedDec 2015

CompletionAug 2016

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)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,302

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach

6 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

December 4, 2015

Completed

4 days until next milestone

Study Start

First participant enrolled

December 8, 2015

Completed

2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2016

Completed

Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

December 4, 2015

Last Update Submit

April 30, 2019

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c after switch to Tresiba®
Month 0, Month 6

Secondary Outcomes (39)

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
+34 more secondary outcomes

Study Arms (1)

Tresiba®

Other: No treatment given

Interventions

No treatment givenOTHER

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.

Tresiba®

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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®

Contact the study team to confirm eligibility.