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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Liraglutide

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Denmark
  • Soeborg, Denmark, 2860
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Number of patients with Victoza® prescriptions	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)	Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date	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)	Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date	From date of first prescription until 24 months
Number of patients who have reached 3.0 mg (Saxenda® only)	Number	12 weeks from time of first prescription
Number of patients with a treatment duration of 0-6 months (Saxenda® only)	Number	Month 6
Number of patients with a treatment duration of 7-12 months (Saxenda® only)	Number	Month 12
Number of patients with a treatment duration of 13-18 months (Saxenda® only)	Number	Month 18
Number of patients with a treatment duration of 19-24 months (Saxenda® only)	Number	Month 24
Number of patients with a treatment duration of 25-36 months (Saxenda® only)	Number	Month 36
Number of patients with a treatment duration of 37-48 months (Saxenda® only)	Number	Month 48
Number of patients with a treatment duration of 49-60 months (Saxenda® only)	Number	Month 60
Number of patients with ongoing treatment (current users) (Saxenda® only)	Number	Month 60

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Reporting Office (2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2018
• Primary Completion (ACTUAL): September 12, 2022
• Study Completion (ACTUAL): September 12, 2022

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (ACTUAL): March 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NN8022-4246; U1111-1185-3276 (OTHER: WHO); EUPAS23369 (REGISTRY: EU PAS Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No