Clinical trial NCT03479762: In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database
Official title: In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.


Eligibility 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

Primary outcomes:
measure: Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only)
timeFrame: Less than 6 months before the date of the first prescription
measure: 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)
timeFrame: Less than 6 months before the date of the first prescription
measure: 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)
timeFrame: Less than 6 months before the first prescription
measure: Number of patients with BMI below 27 kg/m^2 (Saxenda® only)
timeFrame: Less than 6 months before the first prescription
measure: Number of patients with less than 5% weight loss and continuing treatment (Saxenda® only)
timeFrame: Week 0 (first prescription) to week 16; week 24
measure: Mean weight loss in patients not treated according to stopping rule (Saxenda® only)
timeFrame: Week 0 (first prescription) to week 16; week 24
measure: Number of patients with a BMI not measured (Saxenda® only)
timeFrame: Less than 6 months before the first prescription
measure: Number of patients with at least 5% weight loss and continuing treatment (Saxenda® only)
timeFrame: Week 16 - week 24
Secondary outcomes:
measure: 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)
timeFrame: Within 4-12 weeks from the date of the first prescription
measure: Number of initiators with other GLP-1 receptor agonists prescribed during continued treatment with Saxenda® (Saxenda® only)
timeFrame: From date of first prescription until 24 months
measure: Number of initiators with other products for weight management prescribed during continued treatment with Saxenda® (Saxenda® only)
timeFrame: From date of first prescription until 24 months
measure: Number of patients who have reached 3.0 mg (Saxenda® only)
timeFrame: 12 weeks from time of first prescription
measure: Number of patients with a treatment duration of 0-6 months (Saxenda® only)
timeFrame: Month 6
measure: Number of patients with a treatment duration of 7-12 months (Saxenda® only)
timeFrame: Month 12
measure: Number of patients with a treatment duration of 13-18 months (Saxenda® only)
timeFrame: Month 18
measure: Number of patients with a treatment duration of 19-24 months (Saxenda® only)
timeFrame: Month 24
measure: Number of patients with a treatment duration of 25-36 months (Saxenda® only)
timeFrame: Month 36
measure: Number of patients with a treatment duration of 37-48 months (Saxenda® only)
timeFrame: Month 48
measure: Number of patients with a treatment duration of 49-60 months (Saxenda® only)
timeFrame: Month 60
measure: Number of patients with ongoing treatment (current users) (Saxenda® only)
timeFrame: Month 60
Other outcomes:
Locations:
city: Soeborg
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Office (2834)
role: STUDY_DIRECTOR
References: