DiabetesReFLeCTNCT02392117
Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 8 sites in 8 countries.
Trial summary
This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus. 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?
- insulin degludec
- How many people
- 1,262 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 16 Mar 2015to 19 Mar 2018
- 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: Male or female patients aged at least 18 years of age with either T1DM or T2DM (insulin using) (clinically diagnosed) prior to visit 1, who signed an informed consent form, and whose physician plans to start Tresiba® treatment are eligible for entry in this study.
Who may be able to join
- Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
- Male or female patients at least 18 years of age at time of informed consent
- T1DM (diagnosed clinically) prior to inclusion in the study, and/or T2DM, insulin using patients (diagnosed clinically) prior to inclusion in the study
- Planned initiation with Tresiba®
Who cannot join
- Known or suspected hypersensitivity to Tresiba® or any of the excipients listed in Section 6.1 of the SmPC (Summary of Product Characteristics) or related products
- Previous participation in this study (i.e. provision of informed consent)
- Patients who have previously been treated with Tresiba®
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
United Kingdom1 site
Novo Nordisk Investigational Site
London, SW10 9NH
About this study
Official title: A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus
This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.
- Being tested
- insulin degludec
- 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.
insulin degludecDrug
Tresiba® will be prescribed by the physician under normal clinical practice conditions and will be obtained/ purchased from the chemist based on physician prescription. No treatment given.
| Study group | Role | What they receive |
|---|---|---|
| Insulin degludec | Not described Receives: Drug: insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of any hypoglycaemic episodes
Measured: End of 4 week baseline period, end of 12 month observation period
Secondary outcomes (4)
Change from baseline in HbA1c (glycosylated haemoglobin)
Measured: 0- 12 months
Change from baseline in FPG (Fasting Plasma Glucose)
Measured: 0-12 months
Change from the baseline period in the number of severe hypoglycaemic episodes
Measured: 0-12 months
Change from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire ))
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start16 Mar 2015
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prospective
- Enrolment
- 1,262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392117
- Sponsor's protocol ID
- NN1250-4189
- Other IDs
- U1111-1158-0248, ENCEPP/SDPP/7880
- Acronym
- ReFLeCT
- Status last verified
- Sep 2019
- First submitted
- 12 Mar 2015
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Fadini GP, Feher M, Hansen TK, de Valk HW, Koefoed MM, Wolden M, Zimmermann E, Jendle J. Switching to Degludec From Other Basal Insulins Is Associated With Reduced Hypoglycemia Rates: A Prospective Study. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5977-5990. doi: 10.1210/jc.2019-01021.
PubMed 31397845Fadini GP, Giordano C, Salvi L, Nicolucci A; REFLECT Italian Study Group. Reduced Rates of Hypoglycemia in Type 1 or Type 2 Diabetes After Switching to Insulin Degludec: Results from the Italian Cohort of the ReFLeCT Study. Diabetes Ther. 2020 Dec;11(12):2909-2920. doi: 10.1007/s13300-020-00936-5. Epub 2020 Oct 3.
PubMed 33011923de Valk HW, Feher M, Hansen TK, Jendle J, Koefoed MM, Rizi EP, Zimmermann E, Fadini GP. Switching to Degludec is Associated with Reduced Hypoglycaemia, Irrespective of Definition Used or Patient Characteristics: Secondary Analysis of the ReFLeCT Prospective, Observational Study. Diabetes Ther. 2020 Sep;11(9):2159-2167. doi: 10.1007/s13300-020-00875-1. Epub 2020 Jul 14.
PubMed 32666165
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02392117
- Acronym / sponsor ID
- ReFLeCT / NN1250-4189
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,262 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 18 Mar 2015 (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 study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec | – | Drug: insulin degludec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients aged at least 18 years of age with either T1DM or T2DM (insulin using) (clinically diagnosed) prior to visit 1, who signed an informed consent form, and whose physician plans to start Tresiba® treatment are eligible for entry in this study.
Key inclusion criteria (4 listed)
- Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
- Male or female patients at least 18 years of age at time of informed consent
- T1DM (diagnosed clinically) prior to inclusion in the study, and/or T2DM, insulin using patients (diagnosed clinically) prior to inclusion in the study
- Planned initiation with Tresiba®
Key exclusion criteria (4 listed)
- Known or suspected hypersensitivity to Tresiba® or any of the excipients listed in Section 6.1 of the SmPC (Summary of Product Characteristics) or related products
- Previous participation in this study (i.e. provision of informed consent)
- Patients who have previously been treated with Tresiba®
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
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 |
|---|---|---|
| insulin degludecTresiba® will be prescribed by the physician under normal clinical practice conditions and will be obtained/ purchased from the chemist based on physician prescription. No treatment given. | Drug | Insulin degludec |
Primary outcome
Change in the number of any hypoglycaemic episodes
Time frame: End of 4 week baseline period, end of 12 month observation period
4 secondary outcomes
Change from baseline in HbA1c (glycosylated haemoglobin)
Time frame: 0- 12 months
Change from baseline in FPG (Fasting Plasma Glucose)
Time frame: 0-12 months
Change from the baseline period in the number of severe hypoglycaemic episodes
Time frame: 0-12 months
Change from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire ))
Time frame: 0-12 months
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 Oct 2019.
- Results publication: PubMed 31397845Fadini GP, Feher M, Hansen TK, de Valk HW, Koefoed MM, Wolden M, Zimmermann E, Jendle J. Switching to Degludec From Other Basal Insulins Is Associated With Reduced Hypoglycemia Rates: A Prospective Study. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5977-5990. doi: 10.1210/jc.2019-01021.
- Derived from this study: PubMed 33011923Fadini GP, Giordano C, Salvi L, Nicolucci A; REFLECT Italian Study Group. Reduced Rates of Hypoglycemia in Type 1 or Type 2 Diabetes After Switching to Insulin Degludec: Results from the Italian Cohort of the ReFLeCT Study. Diabetes Ther. 2020 Dec;11(12):2909-2920. doi: 10.1007/s13300-020-00936-5. Epub 2020 Oct 3.
- Derived from this study: PubMed 32666165de Valk HW, Feher M, Hansen TK, Jendle J, Koefoed MM, Rizi EP, Zimmermann E, Fadini GP. Switching to Degludec is Associated with Reduced Hypoglycaemia, Irrespective of Definition Used or Patient Characteristics: Secondary Analysis of the ReFLeCT Prospective, Observational Study. Diabetes Ther. 2020 Sep;11(9):2159-2167. doi: 10.1007/s13300-020-00875-1. Epub 2020 Jul 14.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 8 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 8 sites in 8 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 4 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark, Germany, Italy, Netherlands, Spain and 3 more countries. 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 the number of any hypoglycaemic episodes (time frame: End of 4 week baseline period, end of 12 month observation period). 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 NCT02392117, which also lists 3 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 Oct 2019.