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RECRUITING

NCT06338553

EARLY_PHASE1

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

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Optimizing Stage 2 T1DM Management: Assessing the Impact of GLP-1Ra on Metabolic Outcomes in Patients Receiving Teplizumab

Key Details

Gender

All

Age Range

12 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-12

Completion Date

2027-03

Last Updated

2025-12-18

Healthy Volunteers

Conditions

Type 1 Diabetes

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.

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States