Oramed Pharmaceuticals has begun screening patients in its 90-day dose-ranging Pivotal Phase 2b HbA1c clinical study of its oral insulin capsule, ORMD-0801.
A statistically significant improvement in HbA1c (glycated hemoglobin), a long-term gauge of blood glucose control, was observed in just 28 days of treatment with ORMD-0801 in Oramed's prior Phase 2 study. The purpose of this study is to measure this effect over 90 days of treatment at different doses.
The study will enroll approximately 240 patients with type 2 diabetes in multiple centers throughout the U.S. The primary end points are safety evaluating adverse and hypoglycemic events, and efficacy specific to HbA1c levels over 90 days of treatment. Secondary end points include measures of fasting plasma glucose (FPG), post-prandial glucose (PPG levels) during a mixed-meal tolerance test (MMTT) and weight.
"We are very pleased to move forward with this important 90-day treatment study to measure the potential longer-term benefits of our oral insulin capsule on HbA1c in type 2 diabetics," said Oramed CEO, Nadav Kidron.