Cardiovascular DiseasesPhase 3Steno1NCT06082063
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
A Phase 3 study testing Aspirin tablet, Semaglutide and Sotagliflozin in people with Cardiovascular Diseases and Heart Failure, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Failure, Type 1 Diabetes
- What is being tested?
- Aspirin tablet, Semaglutide and Sotagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jul 2024to 1 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Given written informed consent
- 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.
- 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.
- 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.
- Ability to communicate with the investigator and understand informed consent.
Who cannot join
- Type 2 diabetes, MODY, secondary diabetes.
- History of pancreatitis.
- Body mass index < 18.5 kg/m2
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.
- Known or suspected abuse of alcohol or recreational drugs.
- Participant in another intervention study.
- CKD stage 5.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Anne Sophie Mathiesen, N7A, Anne.Sophie.Mathiesen@regionh.dk
- Recruiting
Steno Diabetes Center Copenhagen
Herlev, 2730
Elisabeth Stougaard, MD, PhD, elisabeth.buur.stougaard@regionh.dk
About this study
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.
Read the detailed description
Background: Individuals with type 1 diabetes (T1D) are at high risk for cardiovascular disease (CVD). Even with optimal glycemic control, the risk is doubled compared to healthy individuals. Treatment of type 2 diabetes (T2D) is based on multifactorial intervention (MFI). The development of new drug classes has had profound impact on treatment guidelines through a documented reduction in mortality and morbidity in individuals with T2D. MFI acknowledges the need for control and interventions directed towards several risk factors for CVD, and not focus merely on glucose levels. A fundamental change in risk management with a strong focus on MFIs to lower CVD risk in individuals with T1D and comorbidity of CVD, CKD, HF or obesity, has the potential to improve morbidity and survival in T1D.
Objective: The aim of the Steno 1 study is to test MFI in individuals with T1D at high risk of CVD with ambitious treatment targets. We hypothesize, that the MFI reduces major adverse cardiovascular endpoints (MACE) hospitalization for heart failure (HHF), kidney failure and mortality.
Design: This study uses a PROBE design (prospective, cluster-randomized, open, blinded endpoint evaluation), as it will not be possible to mask the MFI. The study is a superiority trial.
Patient population: High-risk individuals with T1D of >10 years duration (>40 years of age with presence of either CKD, CVD, HF, obesity or a >10% 5-year CVD risk determined by the Steno T1 Risk Engine). Participants are recruited from Steno Diabetes Centres or partner clinics.
Randomization: There will be formed three clusters (large patient pool, intermediate- and small). Within each cluster, participating centers will be randomised to either group A or group B. Group A will receive current guideline-recommended standard of care and group B will receive the multifactorial risk based intensive therapy. Participants are allocated to centers based on geography and not based on phenotype.
Intervention: For the intensively treated group, the MFI will be determined by the risk profile and risk markers of each individual and the participants will be allocated to Semaglutide, sotagliflozin, finerenone, ezetimibe and/ or PCSK9-inhibitors. The intervention will also comprise more ambitious treatment targets for blood pressure and lipid levels. In addition, all participants will take aspirin 75 mg OD.
Endpoints: The primary endpoint is to determine whether MFI 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). Secondary endpoints are to determine whether MFI is superior to standard care with respect to all-cause mortality, a composite endpoint of renal function (end-stage kidney disease (ESKD) (dialysis, renal death, transplantation) or >50% sustained decline in eGFR) compared to standard of care and to determine whether MFI including the use of SGLT2i and GLP1RA leads to an increased frequency of diabetic ketoacidosis compared to standard of care.
- Being tested
- Aspirin tablet, Semaglutide, Sotagliflozin, Finerenone
- Medical subject headings
- Cardiovascular Diseases, Heart Failure, Diabetes Mellitus, Type 1, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin tabletDrug
Antiplatelet treatment: with aspirin 75mg OD is mandatory except for concomitant anticoagulant therapy or allergy. In case of allergy clopidogrel will be used.
SemaglutideDrug
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.
SotagliflozinDrug
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.
FinerenoneDrug
Finerenone: 10 mg once daily titrated to 20 mg as add-on in persons with persistent albuminuria (>30 mg/g) despite RAS blockade.
| Study group | Role | What they receive |
|---|---|---|
| Multifactorial intervention group | Active comparator | The multifactorial intervention will be determined by the risk profile and risk markers of each individual and the participants will be allocated to Semaglutide, sotagliflozin or finerenone. The intervention will also comprise more ambitious treatment targets for blood pressure and lipid levels. In addition, all participants will take aspirin 75 mg OD. Receives: Drug: Aspirin tablet; Drug: Semaglutide; Drug: Sotagliflozin; Drug: Finerenone |
| Standard intervention group | No intervention | During the whole study period the standard intervention shall be done according to current Danish and international (ADA/EASD) guidelines. This will address similar risk factors as in the intensive group, but to a less ambitious treatment target for blood pressure and lipid lowering and will not include the use of SGTL2i, finerenone or GLP-1RA, unless these drug classes become recommended in future versions of guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE + HHF
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).
Measured: 5 years
Secondary outcomes (3)
All-cause mortality
Calculate the incidence of all-cause mortality to determine whether a multifactorial intervention is superior to standard care with respect to all-cause mortality.
Measured: 5 years
Renal function
Calculate the incidence of ESKD to determine whether a multifactorial intervention is superior to standard care with respect to renal function (end-stage kidney disease (ESKD) (dialysis, renal death, transplantation) or >50% sustained decline in eGFR) compared to standard of care.
Measured: 5 years
Diabetic ketoacidosis, safety
Calculate the incidence of DKA to determine whether a multifactorial intervention including the use of SGLT2i and GLP-1RA leads to a change in the frequency of diabetic ketoacidosis compared to standard care.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Jul 2024
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a PROBE design (prospective, cluster-randomized, open, blinded endpoint evaluation). The study is a superiority trial.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Steno Diabetes Center Nordjylland, Steno Diabetes Center Odense, Slagelse Hospital, Nykøbing Falster County Hospital, Zealand University Hospital, Hillerod Hospital, Denmark, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Regionshospitalet Viborg, Skive, Randers Regional Hospital, Herning Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Regionshospitalet Silkeborg, Bispebjerg Hospital, Regionshospitalet Horsens
- Responsible party
- Sponsor
- Investigators
- Peter Rossing, MD, DMSc, Proffessor, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082063
- Sponsor's protocol ID
- NNF 22OC0077730
- Acronym
- Steno1
- Status last verified
- Jan 2025
- First submitted
- 16 May 2023
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rossing P. Experimental Designs for Multicomponent Interventions in Kidney and Cardiometabolic Diseases. J Am Soc Nephrol. 2024 Oct 1;35(10):1438-1441. doi: 10.1681/ASN.0000000000000449. Epub 2024 Jul 5. No abstract available.
PubMed 39078403
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06082063
- Acronym / sponsor ID
- Steno1 / NNF 22OC0077730
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Steno Diabetes Center Nordjylland, Steno Diabetes Center Odense, Slagelse Hospital, Nykøbing Falster County Hospital, Zealand University Hospital, Hillerod Hospital, Denmark, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Regionshospitalet Viborg, Skive, Randers Regional Hospital, Herning Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Regionshospitalet Silkeborg, Bispebjerg Hospital, Regionshospitalet Horsens
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Individuals with type 1 diabetes (T1D) are at high risk for cardiovascular disease (CVD). Even with optimal glycemic control, the risk is doubled compared to healthy individuals. Treatment of type 2 diabetes (T2D) is based on multifactorial intervention (MFI). The development of new drug classes has had profound impact on treatment guidelines through a documented reduction in mortality and morbidity in individuals with T2D. MFI acknowledges the need for control and interventions directed towards several risk factors for CVD, and not focus merely on glucose levels. A fundamental change in risk management with a strong focus on MFIs to lower CVD risk in individuals with T1D and comorbidity of CVD, CKD, HF or obesity, has the potential to improve morbidity and survival in T1D.
Objective: The aim of the Steno 1 study is to test MFI in individuals with T1D at high risk of CVD with ambitious treatment targets. We hypothesize, that the MFI reduces major adverse cardiovascular endpoints (MACE) hospitalization for heart failure (HHF), kidney failure and mortality.
Design: This study uses a PROBE design (prospective, cluster-randomized, open, blinded endpoint evaluation), as it will not be possible to mask the MFI. The study is a superiority trial.
Patient population: High-risk individuals with T1D of >10 years duration (>40 years of age with presence of either CKD, CVD, HF, obesity or a >10% 5-year CVD risk determined by the Steno T1 Risk Engine). Participants are recruited from Steno Diabetes Centres or partner clinics.
Randomization: There will be formed three clusters (large patient pool, intermediate- and small). Within each cluster, participating centers will be randomised to either group A or group B. Group A will receive current guideline-recommended standard of care and group B will receive the multifactorial risk based intensive therapy. Participants are allocated to centers based on geography and not based on phenotype.
Intervention: For the intensively treated group, the MFI will be determined by the risk profile and risk markers of each individual and the participants will be allocated to Semaglutide, sotagliflozin, finerenone, ezetimibe and/ or PCSK9-inhibitors. The intervention will also comprise more ambitious treatment targets for blood pressure and lipid levels. In addition, all participants will take aspirin 75 mg OD.
Endpoints: The primary endpoint is to determine whether MFI 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). Secondary endpoints are to determine whether MFI is superior to standard care with respect to all-cause mortality, a composite endpoint of renal function (end-stage kidney disease (ESKD) (dialysis, renal death, transplantation) or >50% sustained decline in eGFR) compared to standard of care and to determine whether MFI including the use of SGLT2i and GLP1RA leads to an increased frequency of diabetic ketoacidosis compared to standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a PROBE design (prospective, cluster-randomized, open, blinded endpoint evaluation). The study is a superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Multifactorial intervention group | Active comparator | Drug: Aspirin tablet, Drug: Semaglutide, Drug: Sotagliflozin, Drug: FinerenoneThe multifactorial intervention will be determined by the risk profile and risk markers of each individual and the participants will be allocated to Semaglutide, sotagliflozin or finerenone. The intervention will also comprise more ambitious treatment targets for blood pressure and lipid levels. In addition, all participants will take aspirin 75 mg OD. |
| Standard intervention group | No intervention | –During the whole study period the standard intervention shall be done according to current Danish and international (ADA/EASD) guidelines. This will address similar risk factors as in the intensive group, but to a less ambitious treatment target for blood pressure and lipid lowering and will not include the use of SGTL2i, finerenone or GLP-1RA, unless these drug classes become recommended in future versions of guidelines. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Given written informed consent
- 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.
- 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.
- 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.
- Ability to communicate with the investigator and understand informed consent.
Key exclusion criteria (7 listed)
- Type 2 diabetes, MODY, secondary diabetes.
- History of pancreatitis.
- Body mass index < 18.5 kg/m2
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.
- Known or suspected abuse of alcohol or recreational drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin tabletAntiplatelet treatment: with aspirin 75mg OD is mandatory except for concomitant anticoagulant therapy or allergy. In case of allergy clopidogrel will be used. | Drug | Multifactorial intervention group |
| SemaglutideGLP-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 | Multifactorial intervention group |
| SotagliflozinSGLT2i 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 | Multifactorial intervention group |
| FinerenoneFinerenone: 10 mg once daily titrated to 20 mg as add-on in persons with persistent albuminuria (>30 mg/g) despite RAS blockade. | Drug | Multifactorial intervention group |
Primary outcome
MACE + HHF
Time frame: 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).
3 secondary outcomes
All-cause mortality
Time frame: 5 years
Renal function
Time frame: 5 years
Diabetic ketoacidosis, safety
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 39078403Rossing P. Experimental Designs for Multicomponent Interventions in Kidney and Cardiometabolic Diseases. J Am Soc Nephrol. 2024 Oct 1;35(10):1438-1441. doi: 10.1681/ASN.0000000000000449. Epub 2024 Jul 5. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Rossing, MD, DMSc, Proffessor principal investigator
Steno Diabetes Center Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin tablet, Semaglutide and Sotagliflozin in people with Cardiovascular Diseases and Heart Failure, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederik Persson, MD, DMSc (+4521623779, frederik.persson@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE + HHF (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06082063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.