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T1-DISCO

RecruitingPhase 3

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Lead sponsor

University of Colorado, Denver

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Type 1 diabetes

Key I/E criteria

•BMI 20-45•eGFR ≥45

Primary endpoints

•Ascending Aortic Pulse Wave Velocity (AA PWV)•Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)•Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05819138

Org study ID22-0794

Secondary IDR01HL165433

Timeline

Milestones

Study first posted2023-04-19actual

Study start2023-06-21actual

Last update posted2026-03-04actual

Primary completion2027-10-01estimated

Study completion2027-12-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age49 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Glycemic / diabetes

Renal / kidney

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change in Insulin Sensitivity

Time frame:Baseline, month 8

HOMA-IR (insulin sensitivity)