
To assess the safety and efficacy of multiple daily doses of oral insulin (ORMD‐0801) in subjects with type 2 diabetes (T2DM) over 12 weeks. A total of 373 subjects were randomized to active treatment or placebo. Oral insulin (ORMD‐0801) induced more significant reductions in HbA1c compared to a placebo and was safe and well tolerated in individuals with uncontrolled T2DM. The efficacy and safety findings support the continued development of the 8‐mg dose at bedtime, which is currently being evaluated in two Phase 3 trials.
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