Overview

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

Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study plans to learn more about the effect of semaglutide once weekly on intestinal permeability in individuals with type 2 diabetes.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Colorado, Denver
Collaborator:
Novo Nordisk A/S
Criteria
Inclusion Criteria:

1. Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial, except for protocol described
pre-screening activities, which require a separate informed consent.

2. Male or female, age above or equal to 18 years at the time of signing informed
consent.

3. Diagnosed with type 2 diabetes mellitus on metformin monotherapy

4. Hemoglobin A1c <8.0% (<64 mmol/mol) on screening day

5. Body mass index (BMI) 28-38 kg/m2

6. Low-grade inflammation, defined as elevated high sensitivity C-reactive protein (hs-
CRP >2.0 and ≤10 mg/L). Impaired intestinal barrier function results in activation of
inflammatory pathway; therefore, excluding subjects with no evidence of inflammation
(hs-CRP ≤ 2 mg/L) will help to enrich our study population. Similar threshold for
hs-CRP as a marker of "residual inflammatory risk" (29) has been previously used as an
independent predictor of future vascular events (26, 30).

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).