19Aug 2021
Efficacy and safety of 28‐day treatment with oral insulin (ORMD‐0801) in patients with type 2 diabetes mellitus ‐ A randomized placebo‐controlled trial

Efficacy and safety of 28‐day treatment with oral insulin (ORMD‐0801) in patients with type 2 diabetes mellitus ‐ A randomized placebo‐controlled trial

We aimed to assess the safety and efficacy of oral insulin (ORMD‐0801) in type 2 diabetes (T2DM) patients. After a 2‐week washout of other medications, adult metformin‐treated patients with T2DM, were randomized to receive placebo or 16 mg or 24 mg ORMD‐0801, once daily, at bedtime, for 28 days. In total, 188 patients [HbA1c: 7.82 ± 0.88% (placebo) and 8.08 ± 1.11% (pooled ORMD‐0801 group)] were enrolled. In the placebo group, mean night‐time CGM increased from baseline by 13.7 ± 26.1 mg/dL, whereas the increase was significantly smaller in the pooled ORMD‐0801 group [1.7 ± 23.5 mg/dL (p = 0.0120)]. In patients with T2DM, bedtime ORMD‐0801 curbed increases in night‐time glycemia, 24‐hour glycemia and HbA1c, without increasing risk of hypoglycaemia, or safety events as compared to the control arm.

  • #endo-diabetology

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