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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. Oral insulin (ORMD‐0801) induced greater reductions in HbA1c when 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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