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GLP-1 Receptor Agonist

Semaglutide for Early Type 1 Diabetes (GLP-TEP Trial)

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

26%

Nasopharyngitis

Constipation

Influenza

Diabetic retinopathy

Nausea

Gastrooesophageal reflux disease

Back pain

Upper respiratory tract inflammation

Abdominal discomfort

Vomiting

Diarrhoea

Cardiac ablation

Herpes zoster

Ischaemic cerebral infarction

Acute myocardial infarction

Appendicitis

Large intestine polyp

Peritonitis

Sudden hearing loss

Rectal adenocarcinoma

Spinal operation

100%

80%

60%

40%

20%

Study treatment Arm

Oral Semaglutide 3 mg

Oral Semaglutide 7 mg

Oral Semaglutide 14 mg

Dulaglutide 0.75 mg

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.

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