Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes (T1-DISCO)
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria: Age 18-40 years Antibody + Type 1 Diabetes (T1D) <30 years, ≥ 10 years duration Insulin pump or automated insulin delivery systems Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2 Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics) BMI 20-35 kg/m2 Adequate contraceptive method for females Exclusion Criteria: HbA1c >9%, recent diabetic ketoacidosis (DKA) or hospitalization Congenital heart disease, anemia, diabetic retinopathy History/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis Current/planned pregnancy or nursing Uncontrolled thyroid disease or hypertension (HTN) (≥ 160/100 mm Hg despite optimal therapy) Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months Significant systemic illness such as cancer MRI or p-aminohippuric acid (PAH) contraindications, Iodine or glucagon-like peptide-1 receptor agonist (GLP-1RA) allergy
Sites / Locations
- University of Colorado Anschutz Medical CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Semaglutide
Placebo
Participants will receive 0.25 mg once weekly semaglutide injection for 4 weeks. Participants will receive 0.50 mg once weekly semaglutide injection for 4 weeks. Participants will receive 1.0 mg once weekly semaglutide injection for 6 months.
Participants will receive 0.25 mg once weekly placebo injection for 4 weeks. Participants will receive 0.50 mg once weekly placebo injection for 4 weeks. Participants will receive 1.0 mg once weekly placebo injection for 6 months.