Impact of GLP-1Ra on Metabolic Outcomes in Early Stage Type 1 Diabetes
Optimizing Stage 2 T1DM Management: Assessing the Impact of GLP-1Ra on Metabolic Outcomes in Patients Receiving Teplizumab
This study is testing if a new diabetes drug can help people with early stage Type 1 Diabetes improve their blood sugar control and heart health while they are also getting another treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 12 Years to 50 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | teplizumab, immunotherapy |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06338553 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of glucagon-like peptide-1 receptor agonists (GLP-1Ra) on individuals with stage 2 Type 1 Diabetes who are receiving teplizumab treatment. Participants will undergo liquid meal tests under different conditions to assess their blood sugar levels, insulin effectiveness, and blood vessel function. The study employs a crossover design, where participants will receive either the GLP-1Ra drug or a placebo, followed by various blood draws and ultrasound tests. The aim is to determine if GLP-1Ra can improve glycemic control and cardiovascular health in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12-50 years with stage 2 Type 1 Diabetes and specific glycemic criteria.
Not a fit: Patients with significant comorbidities or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood sugar levels and cardiovascular health for patients with early stage Type 1 Diabetes.
How similar studies have performed: Other studies have shown promising results with GLP-1Ra in diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Daniel J Moore, MD, PhD
- Email: metabolism@vumc.org
- Phone: (615) 322- 7427
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.