Study type

Study type

Non-interventional study

Scope of the study

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

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
(A10BB) Sulfonylureas
Sulfonylureas

Medical condition to be studied

Type 2 diabetes mellitus
Acute kidney injury
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

Renal impaired
Hepatic impaired

Estimated number of subjects

300000
Study design details

Main study objective

Objective 1 = To describe the temporal trends of SGLT2 inhibitor use in cohort of commercially insured beneficiaries with T2DM from the U.S. Objective 2 = To evaluate the association between SGLT2 inhibitor initiation and the short-term risk of hospitalized AKI in in cohort of commercially insured beneficiaries from the U.S.

Outcomes

The primary outcome of interest is hospitalized AKI.

Data analysis plan

For our outcomes study will will use an active comparator new-user study design. Cox proportional hazards models will be used to estimate hazard ratios (HRs) and their 95% confidence intervals (CIs) at each respective time point of interest (30-, 60- 90- and 180-days after new-use). In addition, Kaplan-Meier methods will be used to estimate risk differences (RDs) at each respective time point of interest (30-, 60- 90- and 180-days after new-use). The 95% CIs for RDs will be obtained using a non-parametric bootstrap based on 250 resamples. Across all analyses, inverse probability of treatment (IPT) weighting will be used for confounding control.