Effects of semaglutide on heart health in type 1 diabetes
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
This study is testing whether the medication semaglutide can improve heart and kidney health in adults with type 1 diabetes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05819138 on ClinicalTrials.gov |
What this trial studies
This trial investigates how semaglutide, a medication known for its benefits in type 2 diabetes, affects cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. The study involves administering semaglutide or a placebo to participants aged 18-49 who have been diagnosed with type 1 diabetes and meet specific health criteria. The goal is to determine the efficacy of semaglutide in improving health outcomes for this population, as it is not currently FDA-approved for use in type 1 diabetes. The trial is considered experimental and aims to provide insights into potential new treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-49 with a diagnosis of type 1 diabetes who are using insulin pumps or automated insulin delivery systems.
Not a fit: Patients with poorly controlled diabetes, severe complications, or certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular and kidney health for patients with type 1 diabetes.
How similar studies have performed: Other studies have shown positive outcomes with semaglutide in type 2 diabetes, but its effects in type 1 diabetes are still being explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- University of Washington Medicine Diabetes Institute (UWMDI) — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Petter M Bjornstad, MD — University of Washington
- Study coordinator: Kyla Best
- Email: Kyla.Best@cuanschutz.edu
- Phone: 720-777-9500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.