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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
Pivotal Trial
Drug Has Already Been Approved
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8 (visit 4), week 16 (visit 6)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 (visit 4), week 16 (visit 6)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Differences in lactulose mannitol ratio (LMR) test as a measure of intestinal permeability between treatment groups
Secondary study objectives
Differences between treatment groups in Fecal Calprotectin
Differences between treatment groups in Serum zonulin
Differences between treatment groups in plasma IL-6
+4 moreOther study objectives
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 • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Awards & Highlights
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.
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
2021
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,800 Previous Clinical Trials
2,821,890 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,551 Previous Clinical Trials
2,444,864 Total Patients Enrolled
Neda Rasouli, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: SC semaglutide
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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