Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-49
SponsorUniversity of Colorado, Denver
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Semaglutide Pen Injector
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
2University of Colorado Anschutz Medical Campus80045, AuroraColorado, United States
University of Washington Medicine Diabetes Institute (UWMDI)98109, SeattleWashington, United States
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov