drugset / Trial / NCT03467932
A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |