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Glucagon-like peptide-1 (GLP-1) receptor agonist

Semaglutide for Type 2 Diabetes (SIB Trial)

Phase 4
Recruiting
Led By Neda Rasouli, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8 (visit 4), week 16 (visit 6)
Awards & highlights

SIB Trial Summary

This trial will study the effects of semaglutide, given once weekly, on intestinal permeability in people with type 2 diabetes.

Who is the study for?
This trial is for adults over 18 with type 2 diabetes on metformin, a BMI ≥28 kg/m^2, and mild inflammation. They must not have severe kidney disease, recent pancreatitis, certain cancers or genetic conditions like MEN2 or MTC. Pregnant women and those not using effective contraception are excluded.Check my eligibility
What is being tested?
The study tests the effects of Semaglutide—a drug given weekly—on gut health in people with type 2 diabetes by comparing it to a placebo (a substance with no therapeutic effect). Participants will be randomly assigned to receive either Semaglutide or placebo.See study design
What are the potential side effects?
Semaglutide may cause digestive issues such as nausea and constipation, risk of low blood sugar levels when combined with other diabetes medications, possible thyroid tumors, and inflammation of the pancreas.

SIB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 (visit 4), week 16 (visit 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 (visit 4), week 16 (visit 6) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Differences in lactulose mannitol ratio (LMR) test as a measure of intestinal permeability between treatment groups
Secondary outcome measures
Differences between treatment groups in Fecal Calprotectin
Differences between treatment groups in Serum zonulin
Differences between treatment groups in plasma IL-6
+4 more
Other outcome measures
Exploratory: determine the effect of semaglutide as compared to placebo on intestinal microbiota in relation to changes in intestinal permeability and inflammatory markers

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

SIB Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SC semaglutideExperimental Treatment1 Intervention
Participants receive a once weekly, subcutaneous, Semaglutide injection for 16 weeks in addition to the participants background metformin monotherapy. The participants in this arm will begin at a 0.25 mg dose during the randomization visit, at week 4 this will be escalated to a 0.5 mg dose and at week 8 it will be escalated again to a 1.0 mg dose if tolerable by the participant. If the participant cannot tolerate the 0.25 mg dose at randomization or the 0.5 mg dose at week 4 they will be withdrawn from the study.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this arm will be given a once weekly, subcutaneous, placebo injection matching the Semaglutide experimental arm in addition to their background metformin monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,541 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,514 Previous Clinical Trials
2,415,023 Total Patients Enrolled
Neda Rasouli, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
377 Total Patients Enrolled

Media Library

Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04979130 — Phase 4
Type 2 Diabetes Research Study Groups: SC semaglutide, Placebo
Type 2 Diabetes Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT04979130 — Phase 4
Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04979130 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~13 spots leftby Apr 2025