At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ORMD-0801 Capsules and Placebo for Diabetes Mellitus Type 1. Completed, enrolled 25 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.
Fish oil capsules, identical in appearance to the experimental intervention.