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A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes

NCT04150107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-06-02

Study results available
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Summary

This study is a Phase 2 randomized, crossover study comparing ORMD-0801 given QD versus TID in subjects with T1D. Subjects with T1D will have a screening visit (Visit 1) during which they will be required to review and sign the informed consent form. Medical history and demographics will be collected. Vital signs will be measured, physical exam will be performed, and blood and urine samples will be collected for hematology/chemistry/urinalysis

Placebo capsules will be given QD at bedtime during placebo run-in period 10 days prior to randomization.

Conditions

Interventions

DRUG

ORMD-0801 Treatment A

Treatment A: 24 mg (16 mg capsule + 8 mg capsule) Once Daily (QD) at bedtime

DRUG

ORMD-0801 Treatment B

Treatment B: 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals

OTHER

Placebo

Fish oil capsule

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Oramed, Ltd.

    lead INDUSTRY

Principal Investigators

  • Miriam Kidron, PhD · Oramed Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2020-02-06
Completion
2020-03-12
FDA Drug
Yes

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 NCT04150107 on ClinicalTrials.gov