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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03479762
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2018
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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
Obesity Overweight Drug: Liraglutide

Study Design
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Study Type : Observational
Estimated 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 : April 13, 2018
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : July 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Liraglutide

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Less than 6 months before the first prescription ]
    Number

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

  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) [ Time Frame: Less than 6 months before the first prescription ]
    Number

  8. Number of patients with at least 5% weight loss and continuing treatment (Saxenda® only) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 12 weeks from time of first prescription ]
    Number

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

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

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

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

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

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

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

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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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)
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479762


Locations
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Denmark
Novo Nordisk Investigational Site
Soeborg, Denmark, 2860
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03479762    
Other Study ID Numbers: NN8022-4246
U1111-1185-3276 ( Other Identifier: WHO )
EUPAS23369 ( Registry Identifier: EU PAS Register )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Liraglutide
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists