OzStar has initiated activities associated with the conduct of a proof-of-concept clinical trial and has received approval for the conduct of this trial in Australia from a Human Research Ethics Committee. This trial will further strengthen its therapeutic claims on core discoveries concerning the synergy between its tablet OZ101 and sulphonylurea for the treatment of type 2 diabetes mellitus.
OzStar has received its second grant from the Australian Government to conduct a phase 2 clinical trial using its GMP manufactured OZ101 tablet in patients on existing sulphonylurea-only anti-diabetes drug.
OzStar has commissioned the world-leading clinical research organization, George Clinical, to manage the conduct of this clinical trial. OzStar has designed its clinical trial protocol with the assistance of leading experts. This includes consultation with eminent individuals, who are experts on endocrinology, entero-endocrinology, clinical trial biostatistics, carbohydrate immunology, microbiology and drug development.
Phase 2 Clinical Trial Protocol Design Highlights
This clinical trial has been designed to be a proof-of-concept and signal finding study on the efficacy of different doses of OZ101 as an add-on therapy to sulfonylurea for glycaemic control in patients with T2DM. Patients will be recruited whose diabetes has been treated with sulfonylurea monotherapy for the past 6 months or more but who still exhibit uncontrolled fasting glucose levels (FGL) above 7 mmol/L. The primary aim of the study will be to examine the trajectories on fasting blood glucose, post prandial blood glucose levels and HbA1c in patients treated with OZ101 plus sulphonylurea compared to patients treated only with sulphonylurea.
This study will also assess OZ101 add-on effects on other diabetes markers such as body weight and safety aspects including mild and severe hypoglycaemia. Other diabetes related markers such as pancreas function and blood insulin levels will also be assessed to shed light into the mechanism of action of OZ101 add-on therapy to sulphonylurea. The mechanistic studies will also assess the effects of OZ101 add-on on sulphonylurea absorption and metabolism.