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Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes (T1-DISCO)

The purpose of this study is to learn more about the effects of an investigational drug called semaglutide as a safe and effective means of improving cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes.


Why this Research Matters

Randomized clinical trial to assess the effects of 8 months of once-weekly subcutaneous semaglutide vs. once-weekly placebo injection.


Who can Participate

Adult

Inclusion: Age 18-49 years (1) T1D diagnosis defined as positive T1D-associated antibody(ies) or (2) a clinical diagnosis of T1D plus insulin Insulin pump or automated insulin delivery systems requirement since diagnosis eGFR ≥ 45 ml/min/1.73m2 Adequate contraceptive method for females Stable doses of drugs altering cardiovascular and renal function (e.g., ACEi, ARB, statins, diuretics) BMI 20-45 kg/m2 Exclusion: HbA1c >9%, recent DKA or hospitalization Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy History/family history of medullary thyroid carcinoma, MEN2, pancreatitis Current/planned pregnancy or nursing Uncontrolled thyroid disease or hypertension (≥ 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 Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure) Significant systemic illness such as cancer MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy


Study ID

Protocol Number: 22-0794
More information available at ClinicalTrials.gov: NCT05819138

Meet the Team

Image of Principal Investigator

Kristen Nadeau, MD, MS

Principal Investigator


Locations