Metabolism and Nutrition DisorderNCT02967757
In-market Utilisation of Liraglutide Used for Weight Management in Europe
An observational study of Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 19 sites in 2 countries.
Trial summary
This study is conducted in Europe. The aim of this study is to investigate usage of liraglutide for weight management in clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- liraglutide
- How many people
- 316 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 22 Dec 2016to 28 May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a descriptive study designed to examine in-market utilisation of liraglutide; thus there will be no hypothesis testing and a power calculation is not applicable. 100 patients will be enrolled for the pilot study (50 in each country, ) and additionally 300 patients will be enrolled for the full study (150 in each country)
Who may be able to join
- Initiation of liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg (initiation is defined as no prescription of the same brand within the previous 12 months)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability of the study
Who cannot join
- -Patients or physicians who previously participated in interventional studies for liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg will not be eligible to participate in the study -For the full study, sites and patients included in the pilot will be excluded
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Italy10 sites
Novo Nordisk Investigational Site
Catania, 95122
Novo Nordisk Investigational Site
Chieti, 66100
Novo Nordisk Investigational Site
Cremona, 26900
Novo Nordisk Investigational Site
Novara, 28100
Novo Nordisk Investigational Site
Pisa, 56126
Novo Nordisk Investigational Site
Potenza, 85100
Novo Nordisk Investigational Site
Roma, 00128
Novo Nordisk Investigational Site
Rome, 00168
Novo Nordisk Investigational Site
Rome, 161
Novo Nordisk Investigational Site
Siena, 53100
Germany9 sites
Novo Nordisk Investigational Site
Bad Nauheim, 61231
Novo Nordisk Investigational Site
Bünde, 32257
Novo Nordisk Investigational Site
Essen, 45147
Novo Nordisk Investigational Site
Hamburg, 20097
Novo Nordisk Investigational Site
Kaiserslautern, 67655
Novo Nordisk Investigational Site
Mainz, 55124
Novo Nordisk Investigational Site
München, 81477
Novo Nordisk Investigational Site
Münster, 48143
Novo Nordisk Investigational Site
Ulm, 89073
About this study
Official title: In-market Utilisation of Liraglutide Used for Weight Management in Europe: a Retrospective Medical Record Review Study.
This study is conducted in Europe. The aim of this study is to investigate usage of liraglutide for weight management in clinical practice.
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- liraglutide
- Medical subject headings
- Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Patients will be treated according to routine clinical practice at the discretion of the treating physician. The study will gather data over the course of routine treatment for liraglutide 3.0 mg and liraglutide 1.2 mg/1.8 mg treated patients
| Study group | Role | What they receive |
|---|---|---|
| liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg | Not described Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with BMI above or equal to 30 kg/m^2
Measured: Less than 6 months before date of first prescription
Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity
Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities
Measured: Less than 6 months before date of first prescription
Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities
Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities.
Measured: Less than 6 months before date of first prescription
Number of patients with BMI below 27 kg/m^2
Measured: Less than 6 months before date of first prescription
Number of patients with BMI not measured
Measured: Within 6 months before date of the first prescription
Secondary outcomes (5)
Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day
Measured: From date of first prescription until 24 months
Number of patients with liraglutide 1.2 or 1.8 mg prescriptions and indication of weight management
Measured: From date of first prescription until 24 months
Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg
While adhering to the dose escalation according to label
Measured: By 12 weeks after first prescription date
Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg
Number of patients
Measured: From date of first prescription until 24 months
Number of patients with continued treatment with liraglutide 3.0 mg
Number of patients
Measured: From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start22 Dec 2016
- Primary completion28 May 2019
- Study completion28 May 2019
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 Metabolism and Nutrition DisorderStudies 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
- 316 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
- NCT02967757
- Sponsor's protocol ID
- NN8022-4241
- Other IDs
- U1111-1185-3661, EUPAS16225
- Status last verified
- Jan 2023
- First submitted
- 16 Nov 2016
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Sbraccia P, Aberle J, Olsen AH, Rathor N, Major-Pedersen A. Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study. Diabetes Obes Metab. 2023 Apr;25(4):985-991. doi: 10.1111/dom.14945. Epub 2023 Jan 23.
PubMed 36514273
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-market Utilisation of Liraglutide Used for Weight Management in Europe: a Retrospective Medical Record Review Study.
- ClinicalTrials.gov ID
- NCT02967757
- Acronym / sponsor ID
- NN8022-4241
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 18 Nov 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 this study is to investigate usage of liraglutide for weight management in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg | – | Drug: liraglutide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a descriptive study designed to examine in-market utilisation of liraglutide; thus there will be no hypothesis testing and a power calculation is not applicable. 100 patients will be enrolled for the pilot study (50 in each country, ) and additionally 300 patients will be enrolled for the full study (150 in each country)
Key inclusion criteria (2 listed)
- Initiation of liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg (initiation is defined as no prescription of the same brand within the previous 12 months)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability of the study
Key exclusion criteria (1 listed)
- -Patients or physicians who previously participated in interventional studies for liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg will not be eligible to participate in the study -For the full study, sites and patients included in the pilot will be excluded
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 |
|---|---|---|
| liraglutidePatients will be treated according to routine clinical practice at the discretion of the treating physician. The study will gather data over the course of routine treatment for liraglutide 3.0 mg and liraglutide 1.2 mg/1.8 mg treated patients | Drug | liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg |
Primary outcome
Number of patients with BMI above or equal to 30 kg/m^2
Time frame: Less than 6 months before date of first prescription
Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity
Time frame: Less than 6 months before date of first prescription
Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities
Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities
Time frame: Less than 6 months before date of first prescription
Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities.
Number of patients with BMI below 27 kg/m^2
Time frame: Less than 6 months before date of first prescription
Number of patients with BMI not measured
Time frame: Within 6 months before date of the first prescription
5 secondary outcomes
Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day
Time frame: From date of first prescription until 24 months
Number of patients with liraglutide 1.2 or 1.8 mg prescriptions and indication of weight management
Time frame: From date of first prescription until 24 months
Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg
Time frame: By 12 weeks after first prescription date
Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg
Time frame: From date of first prescription until 24 months
Number of patients with continued treatment with liraglutide 3.0 mg
Time frame: From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 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 20 Jan 2023.
- Results publication: PubMed 36514273Sbraccia P, Aberle J, Olsen AH, Rathor N, Major-Pedersen A. Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study. Diabetes Obes Metab. 2023 Apr;25(4):985-991. doi: 10.1111/dom.14945. Epub 2023 Jan 23.
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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
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 19 sites in 2 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 2 inclusion and 1 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy, Germany. 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?
Number of patients with BMI above or equal to 30 kg/m^2 (time frame: Less than 6 months before date of first prescription). The study lists 5 primary outcomes in all. 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 NCT02967757, 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 20 Jan 2023.