Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes (T1-DISCO)

March 3, 2026 updated by: University of Colorado, Denver
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Principal Investigator:
          • Kristen Nadeau, MD, MS
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington Medicine Diabetes Institute (UWMDI)
        • Principal Investigator:
          • Petter Bjornstad, M.D.
        • Contact:
          • Amanda Bard
          • Phone Number: 504-521-7822
          • Email: abard@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide

Participants will receive 0.25 mg once weekly semaglutide injection for 4 weeks.

Participants will receive 0.50 mg once weekly semaglutide injection for 4 weeks.

Participants will receive 1.0 mg once weekly semaglutide injection for 6 months.
Drug: Semaglutide Pen Injector
Semaglutide injection
Other Names:
  • Ozempic
Placebo Comparator: Placebo
Participants will receive 0.25 mg once weekly placebo injection for 4 weeks. Participants will receive 0.50 mg once weekly placebo injection for 4 weeks. Participants will receive 1.0 mg once weekly placebo injection for 6 months.
Drug: Placebo
Semaglutide placebo injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, month 8
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.
Baseline, month 8
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.
Baseline, month 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, month 8
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.
Baseline, month 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Kristen Nadeau, MD, MS, University of Colorado, Denver
  • Principal Investigator: Petter M Bjornstad, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0794
  • R01HL165433 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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