DiabetesNCT02754817
A Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 5 sites in 5 countries.
Trial summary
This study is conducted in Europe. The aim of the study is to investigate the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 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 2
- What is being tested?
- insulin degludec/liraglutide
- How many people
- 611 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 26 Apr 2016to 20 Oct 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: This study will include adults with T2DM. Collecting data reported in medical records of patients with T2DM who received their first prescription of Xultophy® at least 6 months prior to inclusion in this study, no matter whether Xultophy® was continued afterwards.
Who may be able to join
- Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to extraction of data according to the protocol)
- Male or female patients at least 18 years of age at time of informed consent
- Diagnosis of T2DM (type 2 diabetes mellitus)
- Xultophy® initiation prescribed at least 6 months before inclusion in this study (i.e., date of signed informed consent). Patients may or may not be continuing Xultophy® at study inclusion
- Minimum available data:a.) At the time of Xultophy® prescription: HbA1c value (or if unavailable, the most recent HbA1c value within 6 months before the first Xultophy® prescription);b.) At 6 months plus/minus 45 days after first Xultophy® prescription: HbA1c value
Who cannot join
- Type 1 diabetes
- Previous participation in this study. Participation is defined as having provided informed consent
- Participation in a clinical trial within 6 months before or 12 months after the first Xultophy® prescription (Participation in a non-interventional study is not an exclusion criteria)
- Mental incapacity, unwillingness or inability to provide informed consent, or language barriers precluding adequate understanding or co-operation
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United Kingdom1 site
Novo Nordisk Investigational Site
Stevenage, SG1 4AB
About this study
Official title: A European Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus
This study is conducted in Europe. The aim of the study is to investigate the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin degludec/liraglutide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludec/liraglutideDrug
This is a non-interventional, chart review study and the patients are treated according to current clinical practice and local licenses upon the treating physicians' decision.
| Study group | Role | What they receive |
|---|---|---|
| Insulin degludec/liraglutide | Not described Receives: Drug: insulin degludec/liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (Hemoglobin A1c)
Measured: week 0, week 26
Secondary outcomes (4)
Change in HbA1c
Measured: Month 0, month 3, month 9, months 12
Percentage of responders for HbA1c below 7 percent (53 mmol/mol)
Measured: At 3, 6, 9 and 12 months
Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain
Measured: At 3, 6, 9 and 12 months
Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes
Measured: At 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start26 Apr 2016
- Primary completion20 Oct 2016
- Study completion20 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 611 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
- NCT02754817
- Sponsor's protocol ID
- NN9068-4264
- Other IDs
- U1111-1176-6538
- Status last verified
- Jan 2018
- First submitted
- 27 Apr 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Price H, Bluher M, Prager R, Phan TM, Thorsted BL, Schultes B; EXTRA study group. Use and effectiveness of a fixed-ratio combination of insulin degludec/liraglutide (IDegLira) in a real-world population with type 2 diabetes: Results from a European, multicentre, retrospective chart review study. Diabetes Obes Metab. 2018 Apr;20(4):954-962. doi: 10.1111/dom.13182. Epub 2018 Jan 11.
PubMed 29205856
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. 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 Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02754817
- Acronym / sponsor ID
- NN9068-4264
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 20 Oct 2016 (actual)
- Study completion
- 20 Oct 2016 (actual)
- First posted
- 28 Apr 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 study is conducted in Europe. The aim of the study is to investigate the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec/liraglutide | – | Drug: insulin degludec/liraglutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adults with T2DM. Collecting data reported in medical records of patients with T2DM who received their first prescription of Xultophy® at least 6 months prior to inclusion in this study, no matter whether Xultophy® was continued afterwards.
Key inclusion criteria (5 listed)
- Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to extraction of data according to the protocol)
- Male or female patients at least 18 years of age at time of informed consent
- Diagnosis of T2DM (type 2 diabetes mellitus)
- Xultophy® initiation prescribed at least 6 months before inclusion in this study (i.e., date of signed informed consent). Patients may or may not be continuing Xultophy® at study inclusion
- Minimum available data:a.) At the time of Xultophy® prescription: HbA1c value (or if unavailable, the most recent HbA1c value within 6 months before the first Xultophy® prescription);b.) At 6 months plus/minus 45 days after first Xultophy® prescription: HbA1c value
Key exclusion criteria (4 listed)
- Type 1 diabetes
- Previous participation in this study. Participation is defined as having provided informed consent
- Participation in a clinical trial within 6 months before or 12 months after the first Xultophy® prescription (Participation in a non-interventional study is not an exclusion criteria)
- Mental incapacity, unwillingness or inability to provide informed consent, or language barriers precluding adequate understanding or co-operation
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 degludec/liraglutideThis is a non-interventional, chart review study and the patients are treated according to current clinical practice and local licenses upon the treating physicians' decision. | Drug | Insulin degludec/liraglutide |
Primary outcome
Change in HbA1c (Hemoglobin A1c)
Time frame: week 0, week 26
4 secondary outcomes
Change in HbA1c
Time frame: Month 0, month 3, month 9, months 12
Percentage of responders for HbA1c below 7 percent (53 mmol/mol)
Time frame: At 3, 6, 9 and 12 months
Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain
Time frame: At 3, 6, 9 and 12 months
Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes
Time frame: At 3, 6, 9 and 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 12 Jan 2018.
- Results publication: PubMed 29205856Price H, Bluher M, Prager R, Phan TM, Thorsted BL, Schultes B; EXTRA study group. Use and effectiveness of a fixed-ratio combination of insulin degludec/liraglutide (IDegLira) in a real-world population with type 2 diabetes: Results from a European, multicentre, retrospective chart review study. Diabetes Obes Metab. 2018 Apr;20(4):954-962. doi: 10.1111/dom.13182. Epub 2018 Jan 11.
- 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
5 sites in 5 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 2, run by Novo Nordisk A/S at 5 sites in 5 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 5 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 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria, Germany, Sweden, Switzerland, United Kingdom. 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 (Hemoglobin A1c) (time frame: week 0, week 26). 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 NCT02754817, which also lists 1 linked publication.
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 12 Jan 2018.