Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to 49 Years; no BMI minimum stated; conditions: Diabetes Mellitus, Type 1
- Interventions
- Semaglutide Pen Injector; Placebo
- Conditions
- Diabetes Mellitus, Type 1
- Phase and size
- Phase 3 · 60 participants
- Dates
- Start 2023-06-21
Primary completion 2027-10-01 - Sponsor
- University of Colorado, Denver (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in Ascending Aortic Pulse Wave Velocity (AA PWV)Baseline, month 8
- Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)Baseline, month 8
- Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)Baseline, month 8
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.