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Combination with Insulin with or without Metformin In a 26-week double blind trial (Trial 6, NCT03021187), 731 adult patients with type 2 diabetes mellitus inadequately controlled on insulin (basal, basal/bolus or premixed) with or without metformin, were randomized to semaglutide tablets 3 mg, 7 mg and 14 mg orally once daily or placebo once daily

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This means that even if a generic version of tirzepatide enters the market before then, it may not be legally marketed for weight loss until that later date unless a legal challenge to the patent is successful

Although the precise mechanism remains unclear, it is hypothesized that their ototoxic effects stem from lysosomal dysfunction and cochlear cell apoptosis (Della Porta et al