MedTrace Logo

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

NCT04754334 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2023-02-09

No results posted yet for this study

Summary

This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a Double-Blind 26-week Treatment Extension Period.

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Interventions

DRUG

ORMD-0801

Oral Insulin

OTHER

Placebo

Fish Oil

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
2021-03-16
Primary Completion
2023-01-13
Completion
2023-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04754334 on ClinicalTrials.gov