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GLP-1 Receptor Agonist

Participants receiving a semaglutide (Rybelsus®) for Type 1 Diabetes (GLP-TEP Trial)

Q: What specific characteristics or criteria make an individual more suitable for inclusion in this clinical investigation?

Participants aged between 12 and 50 with a confirmed diagnosis of <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> are eligible for inclusion in this study, which aims to enroll approximately 24 individuals.

Q: How many individuals are enrolled as participants in this ongoing medical study?

Affirmative. Information on clinicaltrials.gov highlights the ongoing recruitment efforts for this investigation. The trial was first listed on 6/1/2024 and last revised on 3/22/2024, seeking to enroll a total of 24 participants at a single location.

Q: Are potential participants currently able to apply for enrollment in this research study?

The search for eligible participants is ongoing as documented on clinicaltrials.gov. The trial was initially listed on June 1st, 2024 and last revised on March 22nd of the same year.

Q: Is the trial open to participants who are younger than 60 years old?

Prospective participants must fall between the ages of 12 and 50 to be considered for this research study.

Phase < 1

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up based on the glucose and insulin readings obtained at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 min and calculated approximately 1 month following completion of the mmtt once insulin levels in plasma are resulted.

Awards & highlights

GLP-TEP Trial Summary

This trial aims to see how a type of medication called GLP-1Ra affects people with early Type 1 Diabetes who are undergoing teplizumab treatment. Participants will be given a liquid

Who is the study for?

This trial is for individuals with early-stage Type 1 Diabetes (Stage 2) who are undergoing treatment with teplizumab. Participants should be able to undergo multiple meal tests and blood draws. Specific inclusion and exclusion criteria details were not provided.Check my eligibility

What is being tested?

The study is testing the effects of a GLP-1Ra drug, Semaglutide (Rybelsus®), compared to a placebo in managing blood sugar levels and cardiovascular health during teplizumab treatment for Type 1 Diabetes.See study design

What are the potential side effects?

While specific side effects are not listed, GLP-1Ra drugs like Semaglutide can typically cause digestive issues such as nausea or vomiting, potential low blood sugar events, and may affect heart rate.

GLP-TEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ based on the glucose and insulin readings obtained at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 min and calculated approximately 1 month following completion of the mmtt once insulin levels in plasma are resulted.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~based on the glucose and insulin readings obtained at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 min and calculated approximately 1 month following completion of the mmtt once insulin levels in plasma are resulted.

This trial's timeline: 3 weeks for screening, Varies for treatment, and based on the glucose and insulin readings obtained at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 min and calculated approximately 1 month following completion of the mmtt once insulin levels in plasma are resulted. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the impact of GLP-1Ra on endothelial function in a pilot study

Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study

Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220

29%

Nasopharyngitis

Constipation

Nausea

Upper respiratory tract inflammation

Back pain

Diarrhoea

Decreased appetite

Influenza

Diabetic retinopathy

Atrioventricular block second degree

Abdominal discomfort

Vomiting

Angina pectoris

100%

80%

60%

40%

20%

Study treatment Arm

Dulaglutide 0.75 mg

Oral Semaglutide 3 mg

Oral Semaglutide 7 mg

Oral Semaglutide 14 mg

GLP-TEP Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving a semaglutide (Rybelsus®)Experimental Treatment1 Intervention

Participants receive 7mg of semaglutide (Rybelsus®) orally once before one of the post-TZIELD® MMTTs. Rybelsus is only given one time.

Group II: Participants receiving placeboPlacebo Group1 Intervention

Participants receive a placebo orally once before the pre-TZIELD® MMTT. Participants also receive a placebo orally once before one of the post-TZIELD® MMTTs.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,169 Total Patients Enrolled

Frequently Asked Questions

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

What specific characteristics or criteria make an individual more suitable for inclusion in this clinical investigation?

"Participants aged between 12 and 50 with a confirmed diagnosis of type 1 diabetes are eligible for inclusion in this study, which aims to enroll approximately 24 individuals."

Answered by AI

How many individuals are enrolled as participants in this ongoing medical study?

"Affirmative. Information on clinicaltrials.gov highlights the ongoing recruitment efforts for this investigation. The trial was first listed on 6/1/2024 and last revised on 3/22/2024, seeking to enroll a total of 24 participants at a single location."

Answered by AI

Are potential participants currently able to apply for enrollment in this research study?

"The search for eligible participants is ongoing as documented on clinicaltrials.gov. The trial was initially listed on June 1st, 2024 and last revised on March 22nd of the same year."

Answered by AI