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RecruitingPhase 3

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 49 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how semaglutide affects the heart, blood vessels, kidneys, and how well insulin works in adults ages 18–49 with type 1 diabetes. Semaglutide is not FDA-approved for this use, so this treatment is experimental.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–49.
  • Type 1 diabetes confirmed by an antibody blood test, or diagnosed by a doctor with insulin needed since diagnosis.
  • Use an insulin pump or an automated insulin delivery system.
  • Kidney filtering test result (eGFR) of at least 45.
  • Stable doses of medicines that affect the heart, blood vessels, or kidneys.
  • Body mass index (BMI), a measure of weight compared with height, of 20–45.
  • Females must use an adequate birth control method.

Who can't join

  • HbA1c, a measure of average blood sugar, above 9%; recent diabetic ketoacidosis (dangerous acid buildup from diabetes); or recent hospital stay.
  • Major heart disease present at birth, anemia (low red blood cells), or severe or advanced diabetes-related eye disease.
  • Personal or family history of medullary thyroid cancer, MEN2 (a condition that causes tumors in hormone-making glands), or pancreatitis (swelling of the pancreas).
  • Pregnant, planning pregnancy, or breastfeeding.
  • Uncontrolled thyroid disease or blood pressure of 160/100 or higher despite the best treatment.
  • Use of diabetes medicines other than insulin, medicines that help insulin work better, or steroids that affect the whole body in the past 3 months; or use of medicines called atypical antipsychotics.
  • A serious illness affecting the body, such as cancer, or an allergy to GLP-1 receptor agonists, the drug group that includes semaglutide.
  • Shellfish or iodine allergy prevents only the iohexol kidney test. Health reasons that make MRI scans or PAH tests unsafe prevent only those procedures.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (2)

CO

WA