TARGET-EU: Dapagliflozin and major adverse cardiovascular events in type 2 diabetes

29/05/2026
29/05/2026
EU PAS number:
EUPAS1000000979
Study
Planned
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Study summary
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Study identification

EU PAS number

EUPAS1000000979

Study ID

1000000979

Official title and acronym

TARGET-EU: Dapagliflozin and major adverse cardiovascular events in type 2 diabetes

DARWIN EU® study

No

Study countries

Netherlands
Spain
United Kingdom

Study description

This case study is part of the broader TARGET EU project (EUPAS1000000539), which aims to advance the regulatory use of real-world data through the application of target trial emulation and estimand methodologies.

Background: Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has demonstrated cardiovascular benefits in randomized trials, including reduced hospitalization for heart failure and renal disease progression. Real-world studies have shown that SGLT2 inhibitors consistently reduce hospitalization for heart failure, with some evidence of mortality benefits, but their effects on major atherosclerotic cardiovascular events (MI and stroke) are less consistent.

Objectives:The primary objective is to estimate the effect of initiating dapagliflozin versus a DPP-4 inhibitor on time to first MACE, defined as a composite of non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality among patients who have or are at risk of atherosclerotic cardiovascular disease (ASCVD).

Methods: We will conduct an active comparator new-user cohort study using linked electronic health records from the UK (CPRD GOLD and Aurum) and Spain (BIFAP). Eligible individuals are adults (≥40 years) with T2D and either established ASCVD or high risk of ASCVD, who initiated dapagliflozin or a DPP-4 inhibitor between 2012 and 2024. In the primary analysis, a treatment policy strategy is used for treatment-related intercurrent events (discontinuation, switching, or intensification), and a composite strategy is applied to all-cause death. Inverse probability of treatment weighting (IPTW) is used to estimate treatment effects in the study population. The primary analysis uses a Cox proportional hazards model, with supplemental analyses using an accelerated failure time model to estimate restricted mean survival time at 3 and 5 years. Sensitivity analyses will assess the impact of departures from key assumptions (censoring not random, mis-measurement of treatment)

Study status

Planned
Research institutions and networks

Institutions

Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner

Networks

Contact details

Daniala Weir

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable