Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors
Dipeptidyl peptidase 4 (DPP-4) inhibitors
(A10BJ) Glucagon-like peptide-1 (GLP-1) analogues
Glucagon-like peptide-1 (GLP-1) analogues
(A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Sodium-glucose co-transporter 2 (SGLT2) inhibitors

Medical condition to be studied

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)

Special population of interest

Hepatic impaired
Renal impaired

Estimated number of subjects

300000
Study design details

Main study objective

To assess the effect of exposure on - Effectiveness outcomes (CVD surrogate markers and CVD events) - Safety outcomes (various, depending on drug class)

Data analysis plan

For continuous variable outcomes we will use: linear mixed effects regression models among those exposed to drug of interest that utilise pre-exposure data to control for the expected within-person trajectories in the outcome of interest in the absence of the drug. In order to control for serial autocorrelation between measurements, all models will be fitted with a continuous autoregressive correlation structure (CAR1), explicitly allowing for correlation between measurements that exponentially decayed the further apart they were in time For clinical event outcomes: Analysis of all event outcomes will use first event only. The effects of exposure on the outcome of interest will be investigated using Poisson-likelihood regression models, with an ever/never and cumulative exposure term included. We will focus our inferences on the significance of the cumulative (dose-response) term.