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A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus

NCT04564846 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-05-07

Study results available
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Summary

This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial Screening Visit (Visit 0) to establish their eligibility to participate in the study. At Visit 1 (2 weeks after the Screening Visit), qualifying subjects will be randomized to either ORMD-0801 (8 mg) or matching placebo, study medication will be dispensed and subjects will dose, twice a day, once in the morning prior to breakfast and once at night prior to bedtime

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

ORMD-0801

8 mg capsules of ORMD-0801 (Oral Insulin)

OTHER

Placebo

Placebo capsule (Fish Oil)

Sponsors & Collaborators

  • Oramed, Ltd.

    lead INDUSTRY

Principal Investigators

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

  • Ele Ferrannini, M. D. · CNR Institute of Clinical Physiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2022-06-07
Completion
2022-06-07
FDA Drug
Yes

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 NCT04564846 on ClinicalTrials.gov