This study is conducted to examine the use of canagliflozin for treatment of patients with type 1 diabetes mellitus (T1DM) over time in European countries. The study will answer the research question of “what is the proportion of patients with T1DM among canagliflozin users during the period from January 2016 to December 2022 in Europe and does this proportion change over time?” A total of 5 electronic medical record (EMR) databases will be used for this study. Analysis will be conducted within each database separately. The pattern of canagliflozin use in patients with T1DM, including drug ingredient, total number of prescriptions/dispensing, total days of supply, average days of supply per prescription/dispensing, dosage at the initial use, and days of continuous treatment after the first exposure, will be described (if available). The crude prevalence and incidence of patients with T1DM in canagliflozin users will be calculated by year as well as overall. The trends of annual prevalence and incidence of canagliflozin use in patients with T1DM over the study period will be tested. Individual database-specific results will be combined per country as well as overall when appropriate. The diabetic ketoacidosis (DKA) events that occur in patients with T1DM as well as in patients with type 2 diabetes mellitus (T2DM) after receiving canagliflozin treatment will also be studied and described.
This drug utilization study (DUS) is being conducted per the request of EMA PRAC. Primary objective is 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. Study design is an observational, retrospective cohort study using secondary data. A total of 5 electronic medical record (EMR) databases will be used for this study, including CPRD, IQVIA-Belgium, Italy, Spain, and SIDIAP. Descriptive analysis will be conducted within each database, using the Common Data Model (CDM) and standardized analytics when possible. For patients with T1DM who are treated with canagliflozin, the utilization pattern of canagliflozin, including drug ingredient, total number of prescriptions/dispensing, total days of supply, average days of supply per prescription/dispensing, dosage at the initial use, and days of continuous treatment after the first exposure, will be described (subject to data availability). Continuous variables will be summarized using mean ± standard deviation, median, and interquartile range. Categorical variables will be summarized using counts and proportions. The unadjusted prevalence and incidence 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. If potential nonlinear trends are observed, alternative models for time-trend analysis such as the Joinpoint regression model will be considered. When there is sufficient homogeneity in time-trends across data sources, individual database-specific estimates will be combined per country as well as overall through meta-analysis. DKA events that occur in patients with T1DM as well as in patients with T2DM after the exposure to canagliflozin treatment will also be investigated as exploratory objective.
This is a drug utilization study with no primary outcome measures. DKA events that occur in patients with T1DM and those with T2DM after the exposure to canagliflozin treatment will be investigated as exploratory objective.
Lu Wang - Chief Investigator - Janssen Research & Development LLC
Erica Voss - Corresponding Applicant - Janssen Research & Development LLC
Rupa Makadia - Collaborator - Janssen Research & Development LLC
Zhong Yuan - Collaborator - Janssen Research & Development LLC
HES Admitted Patient Care