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

NCT04817215 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2021-03-26

No results posted yet for this study

Summary

To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.

To assess the safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects on on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

ORMD-0801

Randomized to receive ORMD-0801 8 mg QD or 8 mg BID or matching placebo

Sponsors & Collaborators

  • Royal College of Surgeons in Ireland - Medical University of Bahrain

    collaborator OTHER

  • Oramed, Ltd.

    collaborator INDUSTRY

  • King Hamad University Hospital, Bahrain

    lead OTHER

Principal Investigators

  • Dr. Dalal Alromaihi · King Hamad University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-04-30
Completion
2022-07-31

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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 NCT04817215 on ClinicalTrials.gov