A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
Summary
This double-masked placebo-controlled study will include approximately 450 subjects with
inadequately controlled T2DM on diet control alone or on diet control and metformin
monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week
Double-Blind Treatment Period and a Double-Blind 26-week Treatment Extension Period.