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NCT Number: NCT05819138

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

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.

Recruiting

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semaglutide Pen Injector

Drug

Semaglutide injection

Other names: Ozempic

Placebo

Drug

Semaglutide placebo injection

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in Insulin Sensitivity

    Time frame: Baseline, month 8

    Insulin Sensitivity is a measure of how well the body responds insulin. A higher value indicates a better outcome; a lower value indicates a worse outcome.

  2. Change in Renal Vascular Resistance (RVR)

    Time frame: Baseline, month 8

    RVR is a measure of mean arterial pressure to renal blood flow. A higher value indicates a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Kyla Best

CONTACT

[email protected]

720-777-9500

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: T1-DISCO

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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