Details
In this analysis, we performed signal identification for Ozempic (subcutaneous semaglutide) by monitoring non-pregnancy and non-cancer outcomes among new users of Ozempic (exposure of interest) compared to new users of empagliflozin (active comparator) in the Sentinel Distributed Database (SDD). We conducted this signal identification assessment using an active comparator, new user design to identify incident outcomes following initiation of Ozempic or empagliflozin using Tree-Only Scan analyses among individuals 18 years of age and older with evidence of type 2 diabetes.
The study period includes data from January 1, 2018 to May 31, 2025. We distributed this request to 13 Sentinel Data Partners on December 1, 2025 and included data from seven Data Partners where the propensity score models converged. The Data Partners that were not included in the analysis lacked sufficient exposures to ensure propensity score model convergence.
Statistical alerts generated by this analysis do not on their own represent safety signals. Alerts are triaged in consideration of the study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3).
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.