NCT05819138RecruitingPhase 3
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 Apr 2023
- Start date
- 21 Jun 2023
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Type 1 diabetes
- NCT number
- NCT05819138
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- From 21 Jun 2023 to the primary completion date, 1 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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 PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy
Lab values
- HbA1c \>9%, recent diabetic ketoacidosis (DKA) or hospitalization
- Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure)
Other
- Current/planned pregnancy or nursing
- Use of atypical antipsychotics
Who the study is looking for
- 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
Age in the registry: 18 years to 49 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| University of Washington Medicine Diabetes Institute (UWMDI) Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.