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

Abstract

Aim To assess the safety and efficacy of oral insulin (ORMD‐0801) in patients with type 2 diabetes (T2D). Materials and Methods After a 2‐week washout of other medications, adult metformin‐treated patients with T2D were randomized to receive placebo or 16 or 24 mg ORMD‐0801, once daily, at bedtime, for 28 days. The mean change from baseline weighted mean night‐time glucose levels was determined from 2 nights of continuous glucose monitoring (CGM) recordings during the placebo run‐in and last week of treatment. Results 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 = .0120). Glycaemic control variables (24‐hour, fasting and daytime CGM glucose) also displayed smaller increases with ORMD‐0801 versus placebo. Change from baseline HbA1c was −0.01% in the pooled ORMD‐0801 group versus +0.20% in the placebo group (P = .0149). ORMD‐0801 was well tolerated, with similar adverse event and hypoglycaemia rates as placebo. Conclusions In patients with T2D, bedtime ORMD‐0801 curbed increases in night‐time glycaemia, 24‐hour glycaemia and HbA1c, without increasing the risk of hypoglycaemia or safety events compared with the control arm.

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“…Another ongoing pursuit is the development of oral insulin administration, which would provide a more convenient delivery of insulin in comparison to subcutaneous injection. The oral insulin capsule ORMD-0801, by Oramed, showed promising results in Phase II trials and T2DM patients are currently being enrolled for Phase III to further evaluate the drug’s future potential ( Eldor et al, 2021 ).…”

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“…In 2020, the FDA also approved an oral octreotide capsule that is encapsulated with proprietary excipients (transient permeability enhancer) for the treatment of acromegaly [ 33 ]. An oral insulin (ORMD-0801) with a permeation enhancer is currently in phase III to treat type 2 diabetes [ 255 ].…”

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“…Man wird an die GPPAD-POInT (global platform for the prevention of autoimmune diabetes primary oral insulin trial) erinnert, bei der eine Desensibilisierung durch orales Insulin in hohen Dosen versucht wird, um bei hohem genetischem Risiko für einen Typ-1-Diabetes eine Immuntoleranz zu erreichen [1]. Auch spezielle orale Insulin-Präparationen sind in Entwicklung (Phase 2 abgeschlossen), die durch eine entsprechende pharmakologische Technik erreichen, dass ausreichend intaktes Insulin in die Leber und die Blutbahn gelangt [2]. Im Kapitel "Background and Rationale" des Studienprotokolls der vorliegenden Studie wird die Analogie zu hohen intrauterinen Insulinspiegeln im Fruchtwasser gezogen, die eine entsprechende Wirkung auf Darmwachstum und -reifung haben sollen.…”