Home › Type 1 Diabetes › NCT05819138
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
Who can join
Ages 18 to 49 · All sexes
Full eligibility criteria
Inclusion Criteria: * Age 18-49 years * 1\) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis * 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 20-45 kg/m2 * Adequate contraceptive method for females Exclusion Criteria: * HbA1c \>9%, recent diabetic ketoacidosis (DKA) or hospitalization * Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative 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 * Use of atypical antipsychotics * Significant systemic illness such as cancer * Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure) * MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy
About the study
This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. These procedures are considered to be experimental.
What is being tested
- Semaglutide Pen Injector (drug)
- Placebo (drug)
Sponsor: University of Colorado, Denver · Participants: 60 · Started: Jun 21, 2023
Contact the study team
- Kyla Best · Phone: 720-777-9500
Official record on ClinicalTrials.gov — NCT05819138
Locations in the U.S.
| Colorado | University of Colorado Anschutz Medical Campus, Aurora |
| Washington | University of Washington Medicine Diabetes Institute (UWMDI), Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.