NCT06338553 · Vanderbilt University Medical Center
GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab
(GLP-TEP)
What this study is about
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.
View original scientific description
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 outcome measures
Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study
Time frame: 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 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 study
Time frame: 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.
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 study
Time frame: During 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.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Nashville, Tennessee
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 18, 2025 · Source of record for eligibility and locations