drugset / Trial / NCT01889667

Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM)

NCT01889667 ↗

Phase 2 Completed 30 enrolled Oramed, Ltd. Integrium · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to test the safety and pharmacodynamics of an oral formulation of insulin in subjects with Type 2 Diabetes.

Timeline

Start
2013-06
Primary completion
2013-11
Completion
2013-11

Outcome

Met primary endpoint

release “The trial met its primary endpoint and found that in patients with T2DM, bedtime ORMD-0801 curbed increases in night-time glycemia” oramed.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ORMD-0801 Protein / enzyme biologic — Oral