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Completed

NCT Number: NCT03479762

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Soeborg, 2860, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

No treatment given

Primary outcomes

  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 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)

    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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2018
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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