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Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

NCT04606576 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2023-02-09

No results posted yet for this study

Summary

In this randomized, double-blind, double-dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a 26-week Double-Blind Treatment Extension Period.

Conditions

Interventions

OTHER

Placebo

Fish Oil

DRUG

ORMD-0801 QD

Oral Insulin once per day

DRUG

ORMD-0801 BD

Oral Insulin, twice per day

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Oramed, Ltd.

    lead INDUSTRY

Principal Investigators

  • Miriam Kidron, PhD · Oramed, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2023-01-13
Completion
2023-01-13
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 NCT04606576 on ClinicalTrials.gov