Loading clinical trials...

Comparing Semaglutide Versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus (SIB) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

A Randomized Parallel Comparison of Semaglutide Versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus (SIB)

NCT04979130•University of Colorado, Denver

View on ClinicalTrials.gov

Summary

This study plans to learn more about the effect of semaglutide once weekly on intestinal permeability in individuals with type 2 diabetes.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

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 kg/m2
•6. Low-grade inflammation, defined as elevated high sensitivity C-reactive protein (hs- CRP \>1.0 and ≤10 mg/L). Impaired intestinal barrier function results in activation of inflammatory pathway; therefore, excluding subjects with no evidence of inflammation (hs-CRP ≤ 1 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.
+12 more criteria

Locations (1)

University of Colorado Anschutz

Aurora, Colorado, United States

Key Dates

Start Date

January 1, 2022

Primary Completion Date

October 16, 2024

Completion Date

October 16, 2024

Last Updated

March 20, 2025

Enrollment

ACTUAL participants

Conditions

Type 2 DiabetesChronic InflammationIntestinal Permeability

Interventions

Semaglutide

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

Closed-loop in Adults With Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D