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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479762
• Other study ID #: NN8022-4246
• Secondary ID: U1111-1185-3276E
• Status: Completed
• Start date: April 20, 2018
• Est. completion date: September 12, 2022

Study information

• Verified date: November 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 12, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Liraglutide
No treatment given

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Soeborg

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of patients with BMI below 27 kg/m^2 (Saxenda® only)	Number	Less than 6 months before the first prescription
Primary	Number of patients with less than 5% weight loss and continuing treatment (Saxenda® only)	Number	Week 0 (first prescription) to week 16; week 24
Primary	Mean weight loss in patients not treated according to stopping rule (Saxenda® only)		Week 0 (first prescription) to week 16; week 24
Primary	Number of patients with a BMI not measured (Saxenda® only)	Number	Less than 6 months before the first prescription
Primary	Number of patients with at least 5% weight loss and continuing treatment (Saxenda® only)	Number	Week 16 - week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients who have reached 3.0 mg (Saxenda® only)	Number	12 weeks from time of first prescription
Secondary	Number of patients with a treatment duration of 0-6 months (Saxenda® only)	Number	Month 6
Secondary	Number of patients with a treatment duration of 7-12 months (Saxenda® only)	Number	Month 12
Secondary	Number of patients with a treatment duration of 13-18 months (Saxenda® only)	Number	Month 18
Secondary	Number of patients with a treatment duration of 19-24 months (Saxenda® only)	Number	Month 24
Secondary	Number of patients with a treatment duration of 25-36 months (Saxenda® only)	Number	Month 36
Secondary	Number of patients with a treatment duration of 37-48 months (Saxenda® only)	Number	Month 48
Secondary	Number of patients with a treatment duration of 49-60 months (Saxenda® only)	Number	Month 60
Secondary	Number of patients with ongoing treatment (current users) (Saxenda® only)	Number	Month 60