Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 1
In brief
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.
Key facts
- Study ID
- NCT05819138
- Run by
- University of Colorado, Denver
- People needed
- 60
- Starts
- 2023-06-21
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
- University of Washington Medicine Diabetes Institute (UWMDI) — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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