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In patients with type 2 diabetes inadequately controlled on metformin immediate-release alone, the overall incidence of adverse reactions of hypoglycemia was 1.3% in patients given add-on sitagliptin and 2.1% in patients given add-on placebo

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The compounds safety and pharmacological profile have been comprehensively assessed in rodent models.In preclinical trials, including those involving ovariectomized (OVX) rat models, both low- and high-dose AOD-9604 regimens showed no significant toxicity