NCT05819138PHASE3Recruiting
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
University of Colorado, Denver
Start Date
6/21/2023
Completion Date
12/1/2027
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 Criteria
Age Range: 18 years to 49 years
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
* Use of atypical antipsychotics
* Significant systemic illness such as cancer
* Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure)
* MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy
Interventions
DRUG
Semaglutide Pen Injector
DRUG
Placebo
Conditions
Diabetes Mellitus, Type 1
Locations
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
University of Washington Medicine Diabetes Institute (UWMDI)
Seattle, Washington 98109
United States