Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Washington
University of Washington Medicine Diabetes Institute (UWMDI)
RECRUITING
Seattle
Contact Information
Primary
Kyla Best
Kyla.Best@cuanschutz.edu
720-777-9500
Time Frame
Start Date: 2023-06-21
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 60
Treatments
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.
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov