drugset / Trial / NCT03467932

A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus

NCT03467932 ↗

Phase 2 Completed 373 enrolled Oramed, Ltd. Integrium · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a four-way (Participant, Care Provider, Investigator, Outcomes Assessor) masked (blinded) study designed to explore the efficacy of ORMD-0801 when given in different regimens across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM).

Timeline

Start
2018-05-29
Primary completion
2019-10-21
Completion
2020-02-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator ORMD-0801 Protein / enzyme biologic 8 mg Oral
Comparator ORMD-0801 Protein / enzyme biologic 16 mg Oral
Comparator ORMD-0801 Protein / enzyme biologic 32 mg Oral