Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

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.

Conditions

• Cardiovascular Diseases
• Heart Failure
• Type 1 Diabetes
• Kidney 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.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Steno Diabetes Center Nordjylland

  collaborator OTHER

• Steno Diabetes Center Odense

  collaborator OTHER

• Slagelse Hospital

  collaborator OTHER

• Nykøbing Falster County Hospital

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Regionshospitalet Viborg, Skive

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Herning Hospital

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Regionshospitalet Silkeborg

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Regionshospitalet Horsens

  collaborator OTHER

• Steno Diabetes Center Copenhagen

  lead OTHER

Principal Investigators

• Peter Rossing, MD, DMSc, Proffessor · Steno Diabetes Center Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2029-07-01

Completion

2029-07-01

FDA Drug

Yes

Countries

• Denmark

Study Locations