NCT01889667

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

Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, PK and PD of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With T2DM Who Are Inadequately Controlled With Diet and Exercise or Diet, Exercise and Metformin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Oramed, Ltd. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, Phase II(a), randomized, double-blind, placebo-controlled, parallel group, inpatient study preceded by a 5-day single-blind outpatient placebo run-in period.

Conditions

• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
DRUG	ORMD-0801 Dose # 1	Oral Insulin Formulation
DRUG	ORMD-0801 Dose # 2	Oral Insulin Formulation
DRUG	Placebo	Oil Capsules

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-06-28
• Last updated: 2015-04-16
• Results posted: 2014-10-24

Locations

1 site across 1 country: United States