DiabetesEU-TREATNCT02662114
Investigating the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 7 sites in 6 countries.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 2,302 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 8 Dec 2015to 12 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: T1DM (Type 1 diabetes mellitus) and T2DM (Type 2 diabetes mellitus) patient sample treated with Tresiba® under conditions of routine care.
Who may be able to join
- 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
Who cannot join
- 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®
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Austria2 sites
Novo Nordisk Investigational Site
Vienna, 1130
Novo Nordisk Investigational Site
Vienna, 1230
About this study
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
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)
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Tresiba® | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c after switch to Tresiba®
Measured: Month 0, Month 6
Secondary outcomes (39)
Change in HbA1c after switch to Tresiba®
Measured: 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®
Measured: 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®
Measured: Month 0, Month 12
Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba®
Measured: Month 0, Month 6
Change in the mean FPG level after switch to Tresiba®
Measured: Month 0, Month 12
Tresiba® starting dose at switch and doses
Measured: At 6 months
Tresiba® starting dose at switch and doses
Measured: At 12 months
Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba®
Measured: Month 0, Month 6
Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba®
Measured: Month 0, Month 12
Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®
Measured: Month 0, Month 6
Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®
Measured: Month 0, Month 6
Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®
Measured: Month 0, Month 12
Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®
Measured: Month 0, Month 12
Change in body weight (kg) after switch to Tresiba®
Measured: Month 0, Month 6
Change in body weight (kg) after switch to Tresiba®
Measured: 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®
Measured: -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®
Measured: 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®
Measured: -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®
Measured: 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)
Measured: -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)
Measured: 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)
Measured: -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)
Measured: 0 to +12 months
Change in the number of ER (Emergency Room) visits related to hypoglycaemia after switch to Tresiba®
Measured: -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®
Measured: 0 to +6 months
Change in the number of ER visits related to hypoglycaemia after switch to Tresiba®
Measured: -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®
Measured: 0 to +12 months
Change in the number of HCP (Healthcare professional(s)) visits related to hypoglycaemia after switch to Tresiba®
Measured: -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®
Measured: 0 to +6 months
Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba®
Measured: -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®
Measured: 0 to +12 months
Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®
Measured: -6 to 0 months ie 6 months before switch to Tresiba®
Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®
Measured: 0 to +6 months
Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®
Measured: -12 to 0 months ie 12 months before switch to Tresiba®
Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®
Measured: 0 to +12 months
Percentage of patients continuing Tresiba® post-switch
Measured: At 6 months
Percentage of patients continuing Tresiba® post-switch
Measured: At 12 months
Reason(s) for starting Tresiba®, if available
Measured: Month 0, Month 12
Reason(s) for discontinuing Tresiba®, if applicable and available
Measured: Month 0, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start8 Dec 2015
- Primary completion12 Aug 2016
- Study completion12 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662114
- Sponsor's protocol ID
- NN1250-4240
- Other IDs
- U1111-1170-3128
- Acronym
- EU-TREAT
- Status last verified
- Apr 2019
- First submitted
- 4 Dec 2015
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29106039Tentolouris 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.
PubMed 30879256
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02662114
- Acronym / sponsor ID
- EU-TREAT / NN1250-4240
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,302 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 12 Aug 2016 (actual)
- Study completion
- 12 Aug 2016 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tresiba® | – | Other: No treatment given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- T1DM (Type 1 diabetes mellitus) and T2DM (Type 2 diabetes mellitus) patient sample treated with Tresiba® under conditions of routine care.
Key inclusion criteria (7 listed)
- 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®
Key exclusion criteria (4 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenInformation 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. | Other | Tresiba® |
Primary outcome
Change in HbA1c after switch to Tresiba®
Time frame: Month 0, Month 6
39 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Results publication: PubMed 29106039Siegmund 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.
- Results publication: PubMed 30879256Tentolouris 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria, Denmark, Germany, Greece, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c after switch to Tresiba® (time frame: Month 0, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662114, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.