Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05819138
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 21, 2023
Status verified
Mar 2026
Primary completion
Oct 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Ascending Aortic Pulse Wave Velocity (AA PWV) [ Time Frame: Baseline, month 8 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Kyla Best
[email protected]
720-777-9500
Kristen Nadeau, MD, MS (PRINCIPAL_INVESTIGATOR)
University of Washington Medicine Diabetes Institute (UWMDI)SeattleWashington98109
Amanda Bard
[email protected]
504-521-7822
Petter Bjornstad, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Colorado Anschutz Medical Campus· Aurora, COUniversity of Washington Medicine Diabetes Institute (UWMDI)· Seattle, WA

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