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Group B Active for Type 2 Diabetes
Study Summary
This trial is designed to see if the FDA approved medication of Semaglutide can improve the number, function, and gene expression of subjects' CD34+ endothelial progenitor cells.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your body mass index (BMI) falls between 25 and 45.You have a history of diagnosed cardiovascular disease.You have a history of inflammation in the pancreas.You have a medical device implanted in your body, like a pacemaker, that could cause problems when using the Tanita scale.You have had a stroke or heart attack in the past.You are currently taking any diabetes medication except for metformin.You or someone in your family has had medullary thyroid cancer (MTC).You or someone in your family has a history of a condition called Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2).You have been taking anti-inflammatory drugs regularly for the past 3 months.You have a history of ongoing alcohol or drug abuse.You are currently smoking cigarettes.You have additional factors that increase your risk for cardiovascular disease, such as high blood pressure, heart problems or a family history of heart disease.You have a known or suspected allergy to GLP-1 agonists or any ingredients in the medication.You have any other medical condition that could put your safety at risk if you participate in this clinical trial.
- Group 1: Group A Placebo
- Group 2: Group B Active
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
How many people are being allowed to participate in this trial?
"The most recent information available on clinicaltrials.gov does show that this trial is looking for 40 more patients and is thus actively recruiting individuals. The study was first posted on 8/1/2019, with the 3/21/2022 update being the most recent change."
What is the purpose of this clinical trial?
"59 ongoing trials for Group B Active exist in 766 cities and 55 countries as of now. The first trial began in 2018 and completed Phase 4 drug approval thanks to the 1387 participants. In the years since, 365 more trials have completed."
Can you tell me about other research done on Group B Active?
"Currently, there are 59 different clinical trials ongoing that are researching Group B Active. Of those 59 active trials, 27 have reached Phase 3. Many of the trials for Group B Active take place in Loma Linda, California; however, 3899 locations around the world are running these sorts of tests."
What goals does this research aim to achieve?
"The primary aim of this study, which will run for 24 weeks, is to test CD34+ Endothelial Progenitor Cell Migration against serum SDF1a gradient. Additionally, the team will also be measuring Biochemistry: HbA1c (hemoglobin percent), Biochemistry: LDL over HDl Ratio (ratio of LDL over HDL), and Hip to Waist Ratio (Ratio of Hip to Waist) as secondary outcomes."
Can patients who are over 45 years old participate in this study?
"The age requirement for participants in this clinical trial is that they must be over 30 and under 70 years old."
Are there specific requirements to qualify for this clinical trial?
"This clinical trial is testing a new diabetes medication and is seeking 40 participants that have type 2 diabetes mellitus between the ages of 30 and 70."
Do you have any information about how to sign up for the clinical trial?
"The listing on clinicaltrials.gov says that this research is open for recruitment and has been since August 1st, 2019. The page was last updated on March 21st, 2022 and the study plans to have 40 people total between 1 site."
What are the risks associated with Group B Active?
"There is both prior clinical data supporting Group B Active's safety and efficacy, so it received a score of 3."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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