Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A10) DRUGS USED IN DIABETES
DRUGS USED IN DIABETES

Medical condition to be studied

Retinopathy
Diabetes mellitus
Population studied

Age groups

Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

350000
Study design details

Main study objective

To examine the effect of initiation of incretin‐based therapies (IBRx) relative to other antidiabetic therapies (CompRx) on the incidence of retinopathy based on an active comparator new‐user study design.

Outcomes

Incident Retinopathy

Data analysis plan

IBRx new-users will be compared with new users of CompRx with respect to incidence of retinopathy diagnosis. We will use propensity scores to balance measured risk factors for retinopathy between these cohorts. Hazard rates for retinopathy will be estimated using a Cox proportional hazards model controlling for age and sex as well as any covariates remaining imbalanced after implementation of the propensity score.