Study identification

PURI

https://redirect.ema.europa.eu/resource/44530

EU PAS number

EUPAS43551

Study ID

44530

Official title and acronym

Large-scale evidence generation and evaluation across a network of databases for type 2 diabetes mellitus (LEGEND-T2DM)

DARWIN EU® study

No

Study countries

Spain
United Kingdom (Northern Ireland)
United States

Study description

Therapeutic options for type 2 diabetes mellitus (T2DM) have expanded over the last decade with the emergence of sodium-glucose co-transporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP1) receptor agonists, which reduced the risk of major cardiovascular events in randomized controlled trials. Cardiovascular evidence for older second-line agents, such as sulfonylureas, and direct head-to-head comparisons, including with dipeptidyl peptidase 4 (DPP4) inhibitors, are lacking, leaving a critical gap in our understanding of the relative effects of T2DM agents on cardiovascular risk and on patient-centered safety outcomes. The Large-Scale Evidence Generations Across a Network of Databases for T2DM (LEGEND-T2DM) initiative is a series of systematic, large-scale, multinational, real-world comparative cardiovascular effectiveness and safety studies of all 4 major second-line anti-hyperglycemic agents including SGLT2 inhibitor, GLP1 receptor agonist, DPP4 inhibitor and sulfonylureas and leverages the Observational Health Data Science and Informatics (OHDSI) community that provides access to a global network of administrative claims and electronic health record (EHR) data sources. Across data sources, LEGEND-T2DM will identify all adult, T2DM patients who newly initiate a traditionally second-line T2DM agent, including individuals with and without established cardiovascular disease. Using an active comparator, new-user cohort design, LEGEND-T2DM will execute all pairwise class-vs-class and drug-vs-drug comparisons in each data source that meet a minimum patient count of 1,000 per arm and extensive study diagnostics that assess reliability and generalizability through cohort balance and equipoise to examine the relative risk of cardiovascular and safety outcomes. The primary cardiovascular outcomes include a 3-point and a 4-point composite of major adverse cardiovascular events, and series of safety outcomes.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Marc Suchard

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

US Department of Veterans Affairs, National Institutes of Health
Study protocol
Initial protocol

Protocol_v1_0_0_EUPAS

English (448.23 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable