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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

NCT02094534 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-07-06

Study results available
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Summary

This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring (CGM) device. Patients will be given standardized meals and snacks for the duration of their inpatient visit.

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.

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Oramed, Ltd.

    lead INDUSTRY

Principal Investigators

  • Miriam Kidron, Ph.D. · Oramed, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-08-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02094534 on ClinicalTrials.gov