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

NCT03479762 | Completed

• 3 other identifiers: NN8022-4246U1111-1185-3276EUPAS23369
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (8)

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

  Number

  Less than 6 months before the date of the first prescription

• 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)

  Less than 6 months before the date of the first prescription

• 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)

  Less than 6 months before the first prescription

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

  Number

  Less than 6 months before the first prescription

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

  Number

  Week 0 (first prescription) to week 16; week 24

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

  Week 0 (first prescription) to week 16; week 24

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

  Number

  Less than 6 months before the first prescription

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

  Number

  Week 16 - week 24

Secondary Outcomes (12)

• 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 initiators with other GLP-1 receptor agonists prescribed during continued treatment with Saxenda® (Saxenda® only)

  From date of first prescription until 24 months

• 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

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

  12 weeks from time of first prescription

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

  Month 6

Study Arms (1)

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

Liraglutide DRUG

No treatment given

Liraglutide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Soeborg, 2860, Denmark

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Reporting Office (2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 27, 2018
• Study Start: April 20, 2018
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)