A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics

This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring (CGM) device. Patients will be given standardized meals and snacks for the duration of their inpatient visit.

For the first 3 days, patients will be dosed with placebo 45 minutes prior to each of the day's 3 meals to establish baseline insulin requirements. Patients will be dosed with exogenous insulin according to their normal sliding scale and each patient's daily insulin requirement will be documented. The average daily insulin requirements during the 3 day run-in period will constitute the patient's baseline insulin level. Following the 3 day run-in, the CGM device will be detached, its data download, and the patient refitted with the CGM with a fresh cannula for continued monitoring during the 7-day treatment period. Patients will be randomized 2:1 to receive ORMD-0801 or placebo for the 7-day double-blind treatment period.