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临床试验/NCT03479762
NCT03479762已完成不适用

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

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Not applicable

研究组 & 干预措施

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)

干预措施: Liraglutide (Drug)

结局指标

主要结局

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

时间窗: Less than 6 months before the date of the first prescription

Number

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)

时间窗: 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)

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)

时间窗: 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)

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

时间窗: Less than 6 months before the first prescription

Number

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

时间窗: Less than 6 months before the first prescription

Number

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

时间窗: Week 16 - week 24

Number

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

时间窗: Week 0 (first prescription) to week 16; week 24

Number

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

时间窗: Week 0 (first prescription) to week 16; week 24

次要结局

  • 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 with a treatment duration of 49-60 months (Saxenda® only)(Month 60)
  • 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)
  • Number of patients with a treatment duration of 7-12 months (Saxenda® only)(Month 12)
  • Number of patients with a treatment duration of 13-18 months (Saxenda® only)(Month 18)
  • Number of patients with a treatment duration of 19-24 months (Saxenda® only)(Month 24)
  • Number of patients with a treatment duration of 25-36 months (Saxenda® only)(Month 36)
  • Number of patients with a treatment duration of 37-48 months (Saxenda® only)(Month 48)
  • Number of patients with ongoing treatment (current users) (Saxenda® only)(Month 60)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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