drugset / Trial / NCT02954601

A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus

NCT02954601 ↗

Phase 2 Completed 31 enrolled Oramed, Ltd. Integrium · collab
RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a four-way crossover (non-parallel) study with each subject receiving three of the four arms. The study will enroll approximately 30 adult subjects with T2DM from age 20 to 75 inclusive. Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind placebo run-in. On Day 4, each subject will be randomized to a treatment sequence that will include three treatment assignments for each of three treatment Periods according to the randomization scheme.

Timeline

Start
2016-10
Primary completion
2017-02-24
Completion
2017-03-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator ORMD-0801 Protein / enzyme biologic — Oral