Oramed starts 90-day pivotal dose-ranging study for oral insulin
Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) 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, 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 about 240 patients with Type 2 diabetes in multiple centers throughout the U.S.
The primary endpoints are safety evaluating adverse and hypoglycemic events, and efficacy specific to HbA1c levels over 90 days of treatment. Secondary endpoints include measures of fasting plasma glucose, post-prandial glucose during a mixed-meal tolerance test and weight.