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

NCT02954601 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-07-12

Study results available
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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.

Conditions

Interventions

DRUG

ORMD-0801 (qd)

Dose 1 = ORMD-0801 (qd)

DRUG

ORMD-0801 (bid)

Dose 2 = ORMD-0801 (bid)

DRUG

ORMD-0801 (tid)

Dose 3 = ORMD-0801 (tid)

OTHER

Placebo

fish oil placebo

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Oramed, Ltd.

    lead INDUSTRY

Principal Investigators

  • Joel M Neutel, M. D. · Orange County Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-02-24
Completion
2017-03-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02954601 on ClinicalTrials.gov