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ORMD-0801 for Type 2 Diabetes

Phase 3

Waitlist Available

Research Sponsored by Oramed, Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 26

Awards & highlights

Study Summary

This trial will test if a new diabetes medication is more effective than diet control or diet control and metformin in 450 people with uncontrolled type 2 diabetes. The trial will last for 78 weeks.

Eligible Conditions

Type 2 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in A1C

Secondary outcome measures

The mean change in fasting plasma glucose

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ORMD-0801Experimental Treatment1 Intervention

ORMD-0801 8 mg QD

Group II: PlaceboPlacebo Group1 Intervention

placebo dosed QD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ORMD-0801

2015

Completed Phase 2

~240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

IntegriumIndustry Sponsor

25 Previous Clinical Trials

4,929 Total Patients Enrolled

Oramed, Ltd.Lead Sponsor

13 Previous Clinical Trials

2,106 Total Patients Enrolled

Miriam Kidron, PhDStudy ChairOramed, Ltd.

3 Previous Clinical Trials

747 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific papers mention ORMD-0801?

"Currently, there are 80 ongoing studies for ORMD-0801 with 13 trials in Phase 3. The majority of these studies are located in Sao Luis, MA, but there are 257 locations worldwide conducting trials for ORMD-0801."

Answered by AI

Are people with the relevant medical condition currently able to enroll in this clinical trial?

"That is accurate. The clinicaltrials.gov website has information showing that this research is actively recruiting participants. The listing was first put up on March 16th, 2021 and was updated on April 11th, 2022. The study needs to enroll 450 people at a single site."

Answered by AI

Does this research exclude elderly individuals?

"According to the eligibility requirements for this trial, applicants must be between 18 and 75 years old. Out of the 1483 total studies, 203 are for patients that are younger than the age of majority and 1180 are for senior citizens."

Answered by AI

Are there long-term repercussions to ORMD-0801 treatments?

"ORMD-0801 has received a score of 3 from our team at Power. This is because it is a Phase 3 trial, which suggests that there is existing data to support both its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04754334.