NCT05819138 · University of Colorado, Denver
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
(T1-DISCO)
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.
View original scientific description
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.
Interventions
DRUG
Semaglutide Pen Injector
Semaglutide injection
DRUG
Placebo
Semaglutide placebo injection
Primary outcome measures
Change in Ascending Aortic Pulse Wave Velocity (AA PWV)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, month 8
CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Aurora, Colorado
- Seattle, Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations