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The FDAs decision was largely based on data from the SOUL trial, which included data from more than 9,000 patients who were randomized to oral Semaglutide or a placebo, & all patients had type 2 diabetes in addition to known ASCVD , CKD or both

Results A total of 648,070 adult patients with T2D and NAFLD were identified, and patients were categorized into three different comparison groups based on their drug of interest

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Method We systematically searched PubMed and Embase from inception to 1 May 2025 for cohort studies comparing the effect of combination therapy with SGLT2 inhibitor or GLP-1 RA monotherapy on (cardiovascular) mortality and cardiovascular or kidney endpoints in individuals with type 2 diabetes