Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

NCT06082063 · tracked via the Priya Life Science Denmark tracker

Sponsor

Steno Diabetes Center Copenhagen

Phase

Phase 3

Started

2024-07-01

Last updated

2025-01-10

Condition(s) studied

Cardiovascular DiseasesHeart FailureType 1 DiabetesKidney Failure

Investigational drug(s) / intervention(s)

Aspirin tablet →Semaglutide →Sotagliflozin →Finerenone →

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.

Study 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

Sex

ALL

Min age

40 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: 1. Given written informed consent 2. Male or female patients ≥40 years old with type 1 diabetes (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies ( in accordance with local guidelines)) during \>10 years. 3. Presence of chronic kidney disease (UACR \>30 mg/g or eGFR \< 60 ml/min/1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI\>35 kg/m2) OR 10-year CVD risk \>10% according to Steno Type 1 Risk Engine. 4. Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. Fertile participants will be pregnancy tested every six months with urine HCG. 5. Ability to communicate with the investigator and understand informed consent. Exclusion Criteria: 1. Type 2 diabetes, MODY, secondary diabetes. 2. History of pancreatitis. 3. Body mass index \< 18.5 kg/m2 4. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods. 5. Known or suspected abuse of alcohol or recreational drugs. 6. Participant in another intervention study. 7. CKD stage 5.

Primary outcome measure(s)

MACE + HHF — 5 years
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).

Trial sites (2)

Facility	City	Region	Status
Rigshospitalet	Copenhagen	Denmark	Recruiting
Steno Diabetes Center Copenhagen	Herlev	Denmark	Recruiting

On this site

📄 Ozempic (semaglutide) drug profile →

More Steno Diabetes Center Copenhagen trials in Denmark

Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity - the PRE-STORK-trial Active, not recruiting

Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals Recruiting

The Steno Opti-Bolus-Timing Studies Starting soon

The Postprandial Hypo-Avoid Study Recruiting

Automated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care Starting soon

Other trials for the same condition

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting

Heart Rehabilitation for All Active, not recruiting

SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes Recruiting

Optimised Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease Starting soon

The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06082063 on ClinicalTrials.gov ↗ ← All trials in Denmark