NCT02496000

Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus

Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Diet and Metformin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Oramed, Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Randomized, double-blind, placebo-controlled, parallel group study.

Detailed description

This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel group study. After appropriate screening, approximately 180 male and female patients from up to 33 study centers will be treated in this study. Patients with type 2 diabetes mellitus who are being treated by diet, exercise, untreated with antidiabetic medications or treated with and metformin monotherapy or in combination with one other antidiabetic drug (excluding insulin) are eligible for enrollment.

Conditions

• Diabetes Type 2

Interventions

Type	Name	Description
DRUG	ORMD-0801	Oral Insulin
DRUG	Placebo Comparator	Placebo

Timeline

• Start date: 2015-07-27
• Primary completion: 2016-06-27
• Completion: 2016-09-13
• First posted: 2015-07-14
• Last updated: 2019-11-13
• Results posted: 2017-02-17

Locations

34 sites across 1 country: United States