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

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.

Automated summary

ORMD-0801 effectively controlled night-time glycemia, 24-hour glucose, and HbA1c levels in patients with T2D without increasing the risk of hypoglycemia or adverse events compared to the placebo group.