A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

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.

Timeline

Start

2021-03-16

Primary completion

2023-01-13

Completion

2023-01-13

Outcome

Outcome not reported

Stopped: “The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.”

Drugs

Indications