Details
This analysis performed signal identification for Ozempic (a specific form of semaglutide) by monitoring non-pregnancy and non-cancer outcomes among new users of Ozempic compared to new users of sitagliptin among type 2 diabetics.
The study period includes data from January 1, 2018 to February 28, 2022. We distributed this request to five Sentinel Data Partners on August 12, 2022.
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).
- Report 1: This report contains a cohort of type 2 diabetics that was permitted to have evidence of insulin dispensing in the baseline period.
- Report 2: This report contains a cohort of type 2 diabetics that was not permitted to have evidence of insulin dispensing in the baseline period.
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.