Study S001461

Cardiovascular Outcomes, and Mortality in Danish Patients With Type 2 Diabetes Who Initiate Empagliflozin Versus Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA): A Danish Nationwide Comparative Effectiveness Study [EMPLACEtm]

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT03993132
Study type: OBSERVATIONAL
Status: COMPLETED
Enrollment: 26774
Start: 2018-10-01
Primary completion: 2022-06-16
Lead sponsor: Boehringer Ingelheim
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Empagliflozin; DRUG:Liraglutide
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis [From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.]
Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis [From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0006103	Healthcare Resource Utilization and Costs for Empagliflozin Versus Glucagon-Like Peptide-1 Receptor Agonists in Routine Clinical Care in Denmark. Thomsen RW, Diabetes therapy : research, treatment and education of diabetes and related disorders	2022	Nonrandomized study	PMID 36315384 DOI	cites ClinicalTrials.gov:NCT03993132; registry reference DERIVED:36315384