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 groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov