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CompletedNCT03479762Updated Nov 25, 2022

In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database

An observational study in Obesity and Overweight, sponsored by Novo Nordisk A/S. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2022-11-25.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
105
Sex
All
01

Study summary

This study is conducted in Europe. The aim of this study is to investigate the usage of liraglutide for weight management in clinical practice using the CPRD (Clinical Practice Research Datalink) primary care database.

02

Conditions studied

  • Obesity
  • Overweight

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients in the CPRD primary care database who have been prescribed liraglutide after the UK launch of Saxenda® (and have no liraglutide prescriptions in the previous 12 months)

Inclusion criteria

-New initiators of liraglutide (unbranded, or branded prescription, i.e. Saxenda® or Victoza®), who have no liraglutide prescriptions in the twelve months prior to index date (time of first prescription). Patients must be research standard (registered as "acceptable" in the database) with at least one year of up-to-standard registration prior to their index date

Exclusion criteria

Exclusion Criteria:

-Not applicable

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
105 participants (actual)
Patient registry
No

Groups and cohorts

  • Liraglutide

    Patients in the CPRD primary care database who have been prescribed liraglutide after the UK launch of Saxenda® (and have no liraglutide prescriptions in the previous 12 months)

    Drug: Liraglutide

Interventions

  • DrugLiraglutide

    No treatment given

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What researchers measure

Primary outcomes

  1. Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only)

    Number

    Time frame: Less than 6 months before the date of the first prescription

  2. Number of patients with a BMI above or equal to 27 kg/m^2 and below 30 kg/m^2 and 1 or more comorbidities (Saxenda® only)

    With at least 1 relevant comorbidity: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities)

    Time frame: Less than 6 months before the date of the first prescription

  3. Number of patients with a BMI above or equal to 27 kg/m^2 and less than 30 kg/m^2 and no comorbidities (Saxenda® only)

    None of the relevant comorbidities: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities)

    Time frame: Less than 6 months before the first prescription

  4. Number of patients with BMI below 27 kg/m^2 (Saxenda® only)

    Number

    Time frame: Less than 6 months before the first prescription

  5. Number of patients with less than 5% weight loss and continuing treatment (Saxenda® only)

    Number

    Time frame: Week 0 (first prescription) to week 16; week 24

  6. Mean weight loss in patients not treated according to stopping rule (Saxenda® only)

    Time frame: Week 0 (first prescription) to week 16; week 24

  7. Number of patients with a BMI not measured (Saxenda® only)

    Number

    Time frame: Less than 6 months before the first prescription

  8. Number of patients with at least 5% weight loss and continuing treatment (Saxenda® only)

    Number

    Time frame: Week 16 - week 24

Secondary outcomes

  1. Number of patients fulfilling at least one of the following: 1) a prescription interval corresponding to a daily dose of 3.0 mg, 2) dose information of 3.0 mg per day, or 3) indication of weight management (Victoza® only)

    Number of patients with Victoza® prescriptions

    Time frame: Within 4-12 weeks from the date of the first prescription

  2. Number of initiators with other GLP-1 receptor agonists prescribed during continued treatment with Saxenda® (Saxenda® only)

    Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date

    Time frame: From date of first prescription until 24 months

  3. Number of initiators with other products for weight management prescribed during continued treatment with Saxenda® (Saxenda® only)

    Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date

    Time frame: From date of first prescription until 24 months

  4. Number of patients who have reached 3.0 mg (Saxenda® only)

    Number

    Time frame: 12 weeks from time of first prescription

  5. Number of patients with a treatment duration of 0-6 months (Saxenda® only)

    Number

    Time frame: Month 6

  6. Number of patients with a treatment duration of 7-12 months (Saxenda® only)

    Number

    Time frame: Month 12

  7. Number of patients with a treatment duration of 13-18 months (Saxenda® only)

    Number

    Time frame: Month 18

  8. Number of patients with a treatment duration of 19-24 months (Saxenda® only)

    Number

    Time frame: Month 24

  9. Number of patients with a treatment duration of 25-36 months (Saxenda® only)

    Number

    Time frame: Month 36

  10. Number of patients with a treatment duration of 37-48 months (Saxenda® only)

    Number

    Time frame: Month 48

  11. Number of patients with a treatment duration of 49-60 months (Saxenda® only)

    Number

    Time frame: Month 60

  12. Number of patients with ongoing treatment (current users) (Saxenda® only)

    Number

    Time frame: Month 60

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Study locations

1 site
  • Novo Nordisk Investigational Site
    Soeborg, 2860, Denmark
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References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03479762
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Apr 20, 2018
Primary completion
Sep 12, 2022
Completion
Sep 12, 2022
Last update
Nov 25, 2022

Study contacts

Clinical Reporting Office (2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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