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Warnings Not recommended for use by pregnant and lactating women

[252] [253] The main metabolic pathways involve aromatic para-hydroxylation, aliphatic alpha- and beta-hydroxylation, N -oxidation, N -dealkylation, and deamination

double-blind double-dummy Patients 1864 adult patients with type 2 diabetes on metformin alone or metformin with a sulfonylurea Treatment arms Patients were randomized to RYBELSUS 3 mg (n=466), RYBELSUS 7 mg (n=465), RYBELSUS 14 mg (n=465), or Januvia 100 mg (n=467), all once daily

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This step leads to activation of these compounds to their reactive electrophilic metabolites with potential mutagenic and cancerogenic effect