Outcome Monitoring Following Ozempic Use in Patients with Type 2 Diabetes: A Signal Identification Analysis

    Basic Details
    Date Posted
    Thursday, November 10, 2022
    Status
    In progress
    Medical Product
    Ozempic (semaglutide)
    Description

    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 included data from January 1, 2018 through February 28, 2022.

    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.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2018 – February 28, 2022
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    Individuals 18 years of age and older with evidence of type 2 diabetes
    Data Sources
    Sentinel Distributed Database (SDD)