Comparing Semaglutide Versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus (SIB)

Exclusion Criteria

• •1. Known or suspected hypersensitivity to trial product or related products.
• •2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child- bearing potential and not using a highly effective contraceptive method.
• •3. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
• •4. Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.
• •5. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischemic attack (TIA) within the past 60 days prior to the day of screening.
• •6. Second anti-diabetic agent use within 3 months of screening.
• •7. Chronic kidney disease defined as eGFR \< 30 mL/min/1.73 m2.
• •8. C-reactive protein (hs-CRP \>10.0 mg/L) to eliminate patients with acute inflammatory process at the time of screening.
• •9. Any recent infection or antibiotic use within 3 weeks
• •10. Regular use (more than a week duration) of anti-inflammatory medication (steroid or NSAIDs) within 3 months of screening.
• •11. Regular use (more than a week duration) of any digestive health supplements, such as probiotics or prebiotics within 3 months screening.
• •12. Diagnosis of chronic intestinal inflammatory disease such as Crohn's disease, ulcerative colitis or irritable bowel syndrome.
• •13. Prior bariatric or bowel surgery
• •14. Heart failure presently classified as being in New York Heart Association (NYHA) Class IV.
• •15. Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
• •16. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC).
• •17. History of chronic pancreatitis or history of acute pancreatitis within 6 months of screening.
• •18. Chronic consumption of \> 2 alcoholic standard drinks per day as defined by:
• •* 12 ounces of beer (5% alcohol content).
• •* 8 ounces of malt liquor (7% alcohol content).
• •* 5 ounces of wine (12% alcohol content).
• •* 1.5 ounces or a "shot" of 80-proof (40% alcohol content) distilled spirits or liquor (e.g., gin, rum, vodka, whiskey).