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

Trial ID: NCT06338553

Interventional - Phase 1 - Recruiting

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

• Type 1 Diabetes

Interventions

• Semaglutide (Rybelsus®)
• Placebo

Eligibility

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
• 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

Sponsor

Vanderbilt University Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source: ClinicalTrials.gov

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