Clinical trial

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Recruiting now · Phase 3 · 1 countries · Registry ID NCT05819138

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 49 Years

SexAll

Healthy volunteersNot accepted

ConditionDiabetes Mellitus, Type 1

Full registry 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

Treatments and study arms

Semaglutide Pen Injector

Drug

Semaglutide injection

Placebo

Drug

Semaglutide placebo injection

Primary outcomes

Change in Ascending Aortic Pulse Wave Velocity (AA PWV)Baseline, month 8

AA PWV is a measure of central arterial stiffness. A lower value indicates a better outcome.

Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)Baseline, month 8

CF-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.

Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)Baseline, month 8

CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

University of Colorado Anschutz Medical Campus🇺🇸 Aurora, Colorado, United States

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Kyla BestContact

Email · Call 720-777-9500

Kristen Nadeau, MD, MSPrincipal Investigator

University of Washington Medicine Diabetes Institute (UWMDI)🇺🇸 Seattle, Washington, United States

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Amanda BardContact

Email · Call 504-521-7822

Petter Bjornstad, M.D.Principal Investigator