Actively Recruiting

Early Phase 1
Age: 12Years - 50Years
All Genders
NCT06338553

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

Led by Vanderbilt University Medical Center · Updated on 2025-12-18

24

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 12 and 50 years
  • Body mass index (BMI) between 18-31 kg/m2 for adults or 5th to 95th percentile for pediatric participants
  • Stage 2 Type 1 Diabetes with at least 2 islet auto-antibodies and specific glucose criteria (fasting glucose 100-125 mg/dL, or 2-hour OGTT/MMTT glucose 140-199 mg/dL, or glucose >199 mg/dL at 30, 60, or 90 minutes during OGTT)
  • Early stage 3 Type 1 Diabetes with HbA1c 6.5% to 8.0% at diagnosis or HbA1c 5.7% to 6.4% plus oral glucose test meeting ADA criteria within 3 months before or during screening
  • Early stage 3 diagnosis within 8 weeks of first study visit
Not Eligible

You will not qualify if you...

  • Systolic blood pressure over 140 mmHg or diastolic blood pressure over 100 mmHg
  • Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2
  • Liver enzymes (AST or ALT) more than 2.5 times the upper limit of normal
  • Family history of medullary thyroid carcinoma
  • Diagnosis of pancreatitis or gastroparesis within the past 3 years
  • Use of any diabetes medication, antioxidant vitamin supplements within 2 weeks before study, systemic glucocorticoids, antipsychotics, certain beta-blockers (atenolol, metoprolol, propranolol), niacin, thiazide diuretics, oral contraceptives with more than 35 mcg ethinyl estradiol, growth hormone, immunosuppressants, antihypertensives, or antihyperlipidemics
  • Pregnancy, peri-menopausal or post-menopausal status
  • Active smoking

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

D

Daniel J Moore, MD, PhD

CONTACT

W

Wendi Welch, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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