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RECRUITING
NCT06082063
PHASE3

Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Sponsor: Steno Diabetes Center Copenhagen

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2024-07-01

Completion Date

2029-07-01

Last Updated

2025-01-10

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Finerenone

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