Clincosm LogoSign in Get a demo

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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT05819138
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
60
Enrollment
1
Location
2
Arms
42
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Semaglutide Pen Injector
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in Ascending Aortic Pulse Wave Velocity (AA PWV) [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) [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) [Baseline, month 8]

      CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.

    Secondary Outcome Measures

    1. Change in Insulin Sensitivity [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) [Baseline, month 8]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age 18-40 years

    • Antibody + Type 1 Diabetes (T1D) <30 years, ≥ 10 years duration

    • 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 20-35 kg/m2

    • Adequate contraceptive method for females

    Exclusion Criteria:

    • HbA1c >9%, recent diabetic ketoacidosis (DKA) or hospitalization

    • Congenital heart disease, anemia, diabetic 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

    • Significant systemic illness such as cancer

    • MRI or p-aminohippuric acid (PAH) contraindications, Iodine or glucagon-like peptide-1 receptor agonist (GLP-1RA) allergy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Petter M Bjornstad, MD, University of Colorado - Anschutz Medical Campus
    • Principal Investigator: Kristen Nadeau, MD, MS, University of Colorado - Anschutz Medical Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT05819138
    Other Study ID Numbers:
    • 22-0794
    • R01HL165433
    First Posted:
    Apr 19, 2023
    Last Update Posted:
    Apr 24, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Apr 24, 2023