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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03479762
Collaborator
(none)
200
1
51.1
3.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database
Actual Study Start Date :
Apr 13, 2018
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Jul 15, 2022

Arms and Interventions

Arm Intervention/Treatment
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
No treatment given

Outcome Measures

Primary Outcome Measures

  1. Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only) [Less than 6 months before the date of the first prescription]

    Number

  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) [Less than 6 months before the date of the first prescription]

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

  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) [Less than 6 months before the first prescription]

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

  4. Number of patients with BMI below 27 kg/m^2 (Saxenda® only) [Less than 6 months before the first prescription]

    Number

  5. Number of patients with less than 5% weight loss and continuing treatment (Saxenda® only) [Week 0 (first prescription) to week 16; week 24]

    Number

  6. Mean weight loss in patients not treated according to stopping rule (Saxenda® only) [Week 0 (first prescription) to week 16; week 24]

  7. Number of patients with a BMI not measured (Saxenda® only) [Less than 6 months before the first prescription]

    Number

  8. Number of patients with at least 5% weight loss and continuing treatment (Saxenda® only) [Week 16 - week 24]

    Number

Secondary Outcome Measures

  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) [Within 4-12 weeks from the date of the first prescription]

    Number of patients with Victoza® prescriptions

  2. Number of initiators with other GLP-1 receptor agonists prescribed during continued treatment with Saxenda® (Saxenda® only) [From date of first prescription until 24 months]

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

  3. Number of initiators with other products for weight management prescribed during continued treatment with Saxenda® (Saxenda® only) [From date of first prescription until 24 months]

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

  4. Number of patients who have reached 3.0 mg (Saxenda® only) [12 weeks from time of first prescription]

    Number

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

    Number

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

    Number

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

    Number

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

    Number

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

    Number

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

    Number

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

    Number

  12. Number of patients with ongoing treatment (current users) (Saxenda® only) [Month 60]

    Number

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

-Not applicable

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Soeborg Denmark 2860

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT03479762
Other Study ID Numbers:
  • NN8022-4246
  • U1111-1185-3276
  • EUPAS23369
First Posted:
Mar 27, 2018
Last Update Posted:
Apr 29, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2021