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Semaglutide for Heart Disease Prevention in Type 2 Diabetes (SOUL Trial)
SOUL Trial Summary
This trial is testing whether semaglutide can help prevent heart disease in people with type 2 diabetes.
SOUL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSOUL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT04189848SOUL Trial Design
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Who is running the clinical trial?
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- I have heart, brain blood vessel, leg artery problems, or chronic kidney disease.My heart failure is severe, limiting my ability to carry out any physical activity without discomfort.I haven't taken any GLP-1 receptor agonist drugs in the last 30 days.Your HbA1c level is between 6.5% and 10.0%. This is a test that shows your average blood sugar level over the past few months.I haven't had a heart attack, stroke, or severe chest pain in the last 60 days.I have been diagnosed with type 2 diabetes.I am scheduled for a procedure to improve blood flow to my heart, neck, or limbs.Your latest blood sugar levels, called HbA1c, should be between 6.5% and 10.0%. The test should be no more than 30 days old.I am 50 years old or older.
- Group 1: Oral semaglutide
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other research studies have included Semaglutide?
"In 2018, the first study observing semaglutide was completed by Novo Nordisk. As of now, a total of 124 clinical trials have been concluded with 59 more ongoing. The majority of active studies are based in Markham, Ontario."
Is recruitment for this clinical trial still underway?
"The latest information on clinicaltrials.gov suggests that this study is not longer recruiting patients. Although the exact date is unknown, it was posted between June 17th 2019 and November 11th 2020. There are 1514 other trials that may be of interest and are actively looking for candidates."
How many test subjects are needed for this clinical trial?
"As of right now, this clinical trial is not looking for any more patients. The posting was made on June 17th, 2019 and edited November 11th, 2022. If you're interested in other trials, 1455 studies related to diabetes mellitus type 2 are still enrolling participants while 59 different trials concerning Semaglutide are also open."
Has Semaglutide been cleared for public use by the FDA?
"Semaglutide was given a safety score of 3 by our analysts at Power. This is because Phase 3 trials have both supporting efficacy data and multiple rounds of safety data."
What is Semaglutide's purpose?
"Semaglutide can help patients struggling with weight management, those looking to reduce their calorie intake, and people trying to establish an exercise routine."
What is unique about this clinical trial?
"Semaglutide has been studied in 59 clinical trials spanning 766 cities and 55 countries. The first of these studies began in 2018, involving 1387 patients and sponsored by Novo Nordisk A/S. As of now, 124 Semaglutide trials have completed their Phase 4 drug approval stage."
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