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ORMD-0801 QD 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 26 weeks
Awards & highlights

Study Summary

This trial is testing a new diabetes medication in people who are not well controlled on one to three other diabetes medications. The trial will last for 78 weeks and will have a placebo group.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 26 weeks 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 from baseline in A1C
Secondary outcome measures
Mean change in fasting glucose

Side effects data

From 2022 Phase 2 trial • 7 Patients • NCT04616014
57%
Diarrhia
29%
STEATORRHEA
14%
Bronchitis
14%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
ORMD-0801 QD

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ORMD-0801 QDExperimental Treatment1 Intervention
8 mg ORMD-0801 administered QD at night
Group II: ORMD-0801 BIDExperimental Treatment1 Intervention
8 mg ORMD-0801 administered at night and in the morning 45 minutes before breakfast.
Group III: PlaceboPlacebo Group1 Intervention
Fish Oil
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ORMD-0801 QD
2021
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Oramed, Ltd.Lead Sponsor
13 Previous Clinical Trials
1,742 Total Patients Enrolled
IntegriumIndustry Sponsor
25 Previous Clinical Trials
4,565 Total Patients Enrolled
Miriam Kidron, PhDStudy DirectorOramed, Ltd.
3 Previous Clinical Trials
383 Total Patients Enrolled

Frequently Asked Questions

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

Does this research project only include people below a certain age?

"The age bracket for this trial is 18-75 years old."

Answered by AI

Has the FDA given ORMD-0801 QD its stamp of approval?

"ORMD-0801 QD has received a safety rating of 3. This is due to the fact that ORMD-0801 QD is in Phase 3 clinical trials, suggesting that while there is some data supporting efficacy, there are multiple rounds of data supporting safety."

Answered by AI

How many people are participating in this research study at the most?

"Unfortunately, this study is no longer actively recruiting patients. Although, when it was active, the trial was posted on December 28th 2020 and updated on May 4th 2022. If you're still interested in participating in studies, there are currently 1508 trials searching for participants with type 2 diabetes mellitus and 80 studies involving ORMD-0801 QD that are enrolling patients."

Answered by AI

For whom is this research study meant?

"This clinical trial is looking for 710 participants aged 18-75 who have type 2 diabetes mellitus. In addition to meeting the age requirements, potential patients must also: a. have a negative serum pregnancy test result at Screening; b. agree to avoid becoming pregnant while receiving IP for at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP; c. agree to use an acceptable method of contraception at least 30 days prior to IP administration, during the entire study, and for 30 d following their last dose of IP; d. In the absence of hormonal contraception"

Answered by AI

Are there other similar drugs to ORMD-0801 QD that have been studied?

"As of now, 80 different clinical trials are underway that focus on ORMD-0801 QD. Of these active studies, 13 have progressed to Phase 3 testing. Although the majority of research takes places in Manhasset, New york; there are a total of 257 locations conducting trials for this medication."

Answered by AI

Are new participants being sought for this clinical trial?

"As of right now, this clinical trial is not enrolling patients. However, it's worth noting that the study was posted on December 28th 2020 and was last edited on May 4th, 2022. If you're interested in other studies, there are 1508 trials for type 2 diabetes mellitus and 80 for ORMD-0801 QD that are currently looking for participants."

Answered by AI
Recent research and studies
~164 spots leftby Apr 2025