Recruiting

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

ClinicalTrials.gov IDNCT06338553

PhaseEARLY_PHASE1

Enrollment24

SponsorVanderbilt University Medical Center

Age12 Years

SexALL

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Conditions studied

Type 1 Diabetes

About this study

The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment. This study involves giving participants a liquid meal under different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The meal tests are followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo. Each test involves blood draws before and during the meal test, GLP-1Ra or placebo administration, and an ultrasound to measure blood vessel function. The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population.

Interventions

Drug: Semaglutide (Rybelsus®) — 7 mg single dose of Rybelsus® by mouth once before each MMTT
Drug: Placebo — placebo capsule or tablet once before each MMTT.

Primary outcomes

Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study (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)
Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study (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.)
Determine the impact of GLP-1Ra on endothelial function in a pilot study (During the last 30 minutes of each MMTT, between the 210 and 240 timepoints)
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)

Eligibility information

Aims 1-3: Stage 2 T1DM with TZIELD® and GLP-1Ra Inclusion Criteria: * 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) Exclusion Criteria: * 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 Aim 4: Early Stage 3 T1DM with GLP-1Ra Monotherapy Inclusion Criteria * 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 Criteria * 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

Study locations

Vanderbilt University Medical Center, Nashville, Tennessee 37232 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.