RecruitingPhase 3NCT06082063

Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes


Sponsor

Steno Diabetes Center Copenhagen

Enrollment

2,000 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a combined approach to reducing heart disease risk factors can help adults with type 1 diabetes who are at higher cardiovascular risk. **You may be eligible if...** - You are 40 or older with type 1 diabetes for more than 10 years - You have chronic kidney disease, heart disease, heart failure, obesity (BMI over 35), or a 10-year heart disease risk above 10% - You are able to use contraception if you can become pregnant **You may NOT be eligible if...** - You have type 2 diabetes or another form of diabetes - You have a history of pancreatitis - Your BMI is below 18.5 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin tablet

Antiplatelet treatment: with aspirin 75mg OD is mandatory except for concomitant anticoagulant therapy or allergy. In case of allergy clopidogrel will be used.

DRUGSemaglutide

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.

DRUGSotagliflozin

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.

DRUGFinerenone

Finerenone: 10 mg once daily titrated to 20 mg as add-on in persons with persistent albuminuria (\>30 mg/g) despite RAS blockade.


Locations(2)

Rigshospitalet

Copenhagen, Denmark

Steno Diabetes Center Copenhagen

Herlev, Denmark

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NCT06082063


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