NCT02094534View on ClinicalTrials.gov

A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

August 31, 2014

Study Completion Date

October 31, 2014

Conditions
Diabetes Mellitus Type 1
Interventions
BIOLOGICAL

ORMD-0801 Capsules

API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.

OTHER

Placebo

Fish oil capsules, identical in appearance to the experimental intervention.

Trial Locations (1)

92780

Orange County Research Center, Tustin

Sponsors

Collaborators (1)

Integrium
All Listed Sponsors
collaborator

Integrium

INDUSTRY

lead

Oramed, Ltd.

INDUSTRY