Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

PHASE3RecruitingINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

July 1, 2029

Study Completion Date

July 1, 2029

Conditions
Cardiovascular DiseasesHeart FailureType 1 DiabetesKidney Failure
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.

Trial Locations (2)

2730

RECRUITING

Steno Diabetes Center Copenhagen, Herlev

Unknown

RECRUITING

Rigshospitalet, Copenhagen

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Steno Diabetes Center Nordjylland

OTHER

collaborator

Steno Diabetes Center Odense

OTHER

collaborator

Slagelse Hospital

OTHER

collaborator

Nykøbing Falster County Hospital

OTHER

collaborator

Zealand University Hospital

OTHER

collaborator

Hillerod Hospital, Denmark

OTHER

collaborator

Rigshospitalet, Denmark

OTHER

collaborator

Hvidovre University Hospital

OTHER

collaborator

Regionshospitalet Viborg, Skive

OTHER

collaborator

Randers Regional Hospital

OTHER

collaborator

Herning Hospital

OTHER

collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

collaborator

Regionshospitalet Silkeborg

OTHER

collaborator

Bispebjerg Hospital

OTHER

collaborator

Regionshospitalet Horsens

OTHER

lead

Steno Diabetes Center Copenhagen

OTHER

NCT06082063 - Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes | Biotech Hunter | Biotech Hunter