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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.
- Type 2 Diabetes
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 7 Patients • NCT04616014Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Does this research project only include people below a certain age?
"The age bracket for this trial is 18-75 years old."
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."
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."
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"
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."
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."
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