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Investigating Semaglutide for Early Type 1 Diabetes with Teplizumab

This study is looking at how a drug called semaglutide (Rybelsus®) affects people who are in an early stage of Type 1 Diabetes (Stage 2 T1DM) and are also receiving treatment with teplizumab (TZIELD®). Researchers want to see if semaglutide can help manage blood sugar levels, improve how the body uses insulin, and support healthy blood vessels. You would receive a liquid meal, and then either semaglutide or a placebo (an inactive pill). Blood sugar levels and blood vessel function will be measured. The study aims to see if semaglutide can help delay the need for insulin and improve overall heart and metabolic health.

Study design
This is an interventional study planning to enroll 24 participants. It involves giving participants either semaglutide or a placebo during a meal tolerance test.
What's involved
You would participate in meal tolerance tests where blood samples are taken at various times over 240 minutes, and an ultrasound is performed. Insulin levels will be analyzed approximately one month after the meal test.
Compensation
Not stated in the trial record.
Follow-up
Blood sugar levels are measured during the meal tolerance test (up to 240 minutes). Insulin levels are analyzed about one month after the meal test, and blood vessel function is measured during the last 30 minutes of each meal test.

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NCT06338553

GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab

Recruiting
EARLY_PHASE1Ages 12–50InterventionalBasic science
Vanderbilt University Medical Center
~24 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Semaglutide (Rybelsus®)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study
Measured over During the MMTT in which the participant is randomly selected to receive semaglutide (Rybelsus®), glucose level will be checked at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 minutes
+3 more outcomes measured

Conditions

Type 1 Diabetes

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Tennessee1

Who to contact

Daniel J Moore, MD, PhD
[email protected]
(615) 322- 7427
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age: 12-50 years
BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
Stage 2 T1DM (i.e., ≥ 2 islet auto-antibodies and:
fasting glucose ≥ 100 mg/dL and \< 126 mg/dL OR
2-hr OGTT /MMTT ≥ 140 mg/dL and \< 200 mg/dL OR
During an OGTT having a glucose of \> 199 mg/dL at 30, 60, or 90 minutes)
Age: 12-50 years
BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
Early stage 3 T1DM with either
HbA1c 6.5% to 8.0% at diagnosis OR
HbA1c 5.7% to 6.4% with oral glucose test meeting ADA criteria for stage 3 T1DM within the past three months prior to or during screening visit
Time of stage 3 diagnosis: within eight weeks of first study visit

Exclusion

Comorbidities:
SBP \> 140 mmHg and DBP \> 100 mmHg
eGFR by MDRD equation of \< 60 mL/min/1.73m2
AST or ALT \> 2.5 times ULN
Family history of medullary thyroid carcinoma
Diagnosis of pancreatitis or gastroparesis within the past 3 years
Medications: Any diabetes medication, any antioxidant vitamin supplement (\<2 weeks before a study), any systemic glucocorticoid, antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any OCP with \> 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic
Other: pregnancy, peri- or post-menopausal women, active smoker
DKA history: history of diabetic ketoacidosis requiring hospital admission
Comorbidities:
Family history of medullary thyroid carcinoma
Diagnosis of pancreatitis or gastroparesis within the past 3 years
Medications: Any diabetes medication, any antioxidant vitamin supplement (\<2 weeks before a study), any systemic glucocorticoid, antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any OCP with \> 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic
Other: pregnancy, peri- or post-menopausal women, active smoker

What this trial measures

  • Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot studyDuring the MMTT in which the participant is randomly selected to receive semaglutide (Rybelsus®), glucose level will be checked at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 minutes

    Researchers will measure postprandial glycemia during an MMTT before TZIELD® treatment. After TZIELD®, the effects of placebo versus semaglutide (Rybelsus®),a GLP-1Ra, will be compared.

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

    Researchers will use the oral glucose minimal model to measure DI during an MMTT before and after TZIELD® treatment, comparing the effects of placebo versus Rybelsus®. As an exploratory outcome, β-cell endoplasmic reticulum dysfunction will be determined by measuring the proinsulin-to-C-peptide ratio during the MMTT.

  • Determine the impact of GLP-1Ra on endothelial function in a pilot studyDuring the last 30 minutes of each MMTT, between the 210 and 240 timepoints

    B-mode ultrasound will be used to measure flow-mediated vasodilation (FMD), a bioassay of endothelial function, during each MMTT. Because endothelial cells are often among the first affected by hyperglycemia and insulin resistance, researchers aim to illuminate how GLP-1Ra may mitigate early vascular disease progression.

  • Determine how much GLP-1Ra monotherapy therapy changes the disposition index (DI) in a pilot study of early stage 3 T1DM.During the MMTT in which the participant is randomly selected to receive semaglutide (Rybelsus®), glucose level will be checked at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 minutes

    Researchers will assess the independent effects of GLP-1Ra on the disposition index (DI) by comparing the results between the GLP-1Ra and placebo conditions during four mixed meal tolerance tests (MMTTs): two at baseline shortly after diagnosis and two after a six-month interval.