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Semaglutide for Type 2 Diabetes (SIB Trial)
SIB Trial Summary
This trial will study the effects of semaglutide, given once weekly, on intestinal permeability in people with type 2 diabetes.
SIB 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 • NCT04189848SIB Trial Design
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Who is running the clinical trial?
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- You have had ongoing or recent pancreas inflammation.You have a kidney condition where your kidneys are not working well, based on a test called eGFR.You or someone in your family has a history of a certain type of thyroid cancer.Your blood sugar level (Hemoglobin A1c) is less than 8.0% on the day of the screening.You have slightly higher levels of a protein called C-reactive protein in your blood.You have started using a second type of medication for diabetes within the last 3 months before screening.You have severe heart failure classified as New York Heart Association (NYHA) Class IV.You had an infection or took antibiotics in the last 3 weeks.You have had cancer within the past 5 years, except for certain types of skin cancer.You have been regularly using anti-inflammatory medication like steroids or NSAIDs for more than a week in the last 3 months.You have a BMI of 28 or higher.You have a long-term intestinal condition like Crohn's disease or ulcerative colitis.You have had weight loss surgery or surgery on your stomach or intestines in the past.You drink more than two alcoholic drinks every day.You have been diagnosed with type 2 diabetes and are only taking metformin for treatment.You have had a heart attack, stroke, or hospitalization for heart-related chest pain or mini-stroke in the past 60 days.Your C-reactive protein level is higher than 10.0 mg/L, which could mean you have an ongoing inflammation.
- Group 1: SC semaglutide
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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 previous research has investigated the efficacy of Semaglutide?
"Currently, 58 clinical trials are underway to study the efficacy of Semaglutide. 27 of those in progress have advanced to Phase 3 and 3907 locations across the globe are recruiting patients for these studies. The majority of experiments occur at a single site – located in Loma Linda, California."
How many individuals are currently being considered for inclusion in this trial?
"Indeed, the information available on clinicaltrials.gov confirms that this study is still searching for participants. It was first posted in January 1st 2022 and last updated on April 12th 2022 with a goal of recruiting 42 patients from only one medical centre."
Is there still room for participants in this investigation?
"As per the information on clinicaltrials.gov, this research is actively recruiting participants; it was first advertised on January 1st 2022 and most recently revised in April 12th 2022."
Has this research been conducted previously?
"Currently, there are 58 live studies centred around Semaglutide in 55 countries and 772 cities. The first of these clinical trials was conducted by Novo Nordisk A/S in 2018 with 1387 test subjects and managed to reach Phase 4 drug approval status. Since then, 18439 more such tests have been completed."
Who is the ideal participant for this experimental research?
"This medical trial is looking for 42 volunteers who have type 2 diabetes mellitus and are between 18 to 89 years of age. In addition, participants must provide informed consent before any trial-related activities. Additionally, those chosen should possess a BMI over 28 kg/m2, demonstrate low-grade inflammation with an hs-CRP level ranging from 1.0 mg/L - 10 mg/L, display no evidence of inflammation (hs-CRP ≤1mg/L), be male or female above the age of 18 at time of signing informed consent, have been diagnosed with Type 2 DM on metformin monotherapy and"
What medical conditions is Semaglutide commonly employed to treat?
"Semaglutide is a reliable option for individuals struggling to manage their weight, regulate caloric intake, and stay physically active."
Does the eligibility criteria for this medical trial extend to those younger than 40 years old?
"Eligible patients for this medical research must be between the ages of 18 and 89."
Are there any health hazards associated with Semaglutide usage?
"We have rated semaglutide's safety a 3 due to it already being approved for use in Phase 4 trials."
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