Clinical trial
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Recruiting now · Phase 3 · 1 countries · Registry ID NCT06082063
What this study is about
A prospective, randomised, open-labelled, multi-center study. The aim of the Steno 1 study is to test multifactorial intervention in individuals with type 1 diabetes at high risk of CVD with ambitious treatment targets. We will include 2000 participants. Follow-up is 5 years.
Basic eligibility
Full registry criteria
Treatments and study arms
Aspirin tablet
Antiplatelet treatment: with aspirin 75mg OD is mandatory except for concomitant anticoagulant therapy or allergy. In case of allergy clopidogrel will be used.
Semaglutide
GLP-1RA treatment: With semaglutide once weekly individually stepped highest tolerable dose according to standard guidelines aiming at 1 mg/week for persons with HbA1c \>53 mmol/mol or BMI\>25 kg/m2 and/or ischemic heart disease and/or stroke. For safety see below under benefits and risks. Investigators should pay attention to the need for adjustment in insulin dose after initiation of GLP-1RA treatment.
Sotagliflozin
SGLT2i treatment with sotagliflozin 200 mg once daily for persons with UACR \>30 mg/g and eGFR \< 45 ml/min/1.73 m2 and for persons with a diagnosis of HF. For safety see below under benefits and risks. The limit of eGFR (\<45ml/min) for initiation of SGLT2i treatment is set to reduce risk of ketoacidosis. SGLT2i treatment should not be offered to participants on insulin pump therapy, to reduce risk of ketoacidosis. Investigators should pay attention to the need for adjustment in insulin dose after initiation of SGLT2i treatment.
Finerenone
Finerenone: 10 mg once daily titrated to 20 mg as add-on in persons with persistent albuminuria (\>30 mg/g) despite RAS blockade.
Primary outcomes
Calculate the incidence of cardiovascular events (MACE+HF) to determine whether a multifactorial intervention is superior to standard care with respect to MACE+HHF (composite of time to first non-fatal myocardial infarction, first non-fatal stroke, cardiovascular death or first hospitalization for heart failure).