PCSCVM003617/ A Real-World Database Study of Canagliflozin Utilization in Type 1 Diabetes Patients Over Time among European Countries

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Qualitative study including document analysis and qualitative interviews

Study drug and medical condition

• Name of medicine:
  INVOKANA
• Study drug International non-proprietary name (INN) or common name:
  CANAGLIFLOZIN

  METFORMIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK02) canagliflozin

  canagliflozin
• Medical condition to be studied:
  Type 1 diabetes mellitus

  Type 2 diabetes mellitus

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  14249

Study design details

• Main study objective:
  The primary objectives of this study are to describe the time-trend of canagliflozin utilization in patients with T1DM using real-world databases in European countries with high cumulative exposure, including the UK, Spain, Italy, and Belgium.
• Data analysis plan:
  Analysis will be conducted within each database. The utilization pattern of canagliflozin in patients with type 1 diabetes mellitus (T1DM) will be described, with continuous variables summarized using mean ±standard deviation, median, and interquartile range and categorical variables summarized using counts and proportions. ; The unadjusted prevalence (number of canagliflozin users who are patients with T1DM divided by total number of all existing canagliflozin users) and incidence (number of new canagliflozin users who are patients with T1DM divided by the number of all new users) of patients with T1DM in canagliflozin users will be calculated by year as well as overall. ; The linear trends of annual prevalence and incidence over the study period will be tested using a general linear regression model or the Joinpoint regression model if potential nonlinear trends are observed. ; Individual database-specific estimates will be combined per country as well as overall through meta-analysis.