Screening and Intervention for Subclinical Coronary Artery Disease in Patients With Type 2 Diabetes

NCT05700877 | Recruiting Phase 4 DMC

• 1 other identifier: 2022-500143-21-01
• Study Type: interventional
• Target: 7,300
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators intend to perform a landmark study to answer whether a combined CVD screening and treatment strategy is beneficial for patients with type 2 diabetes (T2DM) without known cardiovascular disease (CVD) The investigators aim to answer the following main research questions: Do screening detected high-risk patients benefit of intensified medical treatment? Is it safe to de-intensify medical treatment among patients with a screening detected low risk of CVD? Does a CVD screening and treatment program improve patient reported health status? Cardiovascular risk remains high in patients with T2DM but unevenly distributed. Our current risk stratification strategies are far from optimal leading to both under- and over-treatment of patients. In recent years, noninvasive imaging of subclinical coronary artery disease by cardiac CT has improved considerably. This allows for easily accessible evaluations of coronary atherosclerosis burden and composition - exceptionally strong imaging biomarkers of future cardiovascular disease. An increasing amount of data suggests that cardiac CT may permit better risk stratification in patients with T2DM. At the same time, the pharmaceutical treatment of T2DM has changed with several new and expensive drug classes, each individually documented to reduce the risk for new or recurrent cardiovascular events. Thus, these new drugs may improve outcome in high-risk patients, whereas they may be wasteful and only lead to side effects in low-risk patients. In the Inten-CT study, the investigators combine these two pivotal developments. The investigators intend to improve risk stratification of patients with T2DM by use of cardiac CT and, based on this knowledge, the investigators wish to investigate if upgraded medical treatment in the high-risk population is beneficial and if de-intensified treatment in the low-risk population is safe. As a secondary aim, the investigators wish to investigate if such a strategy improves patient reported health status. These aims are in agreement with one of the important health indicators from The Danish College of General Practitioners: "We find and treat the patients and let the healthy stay healthy". The investigators intend with this strategy to improve not only cardiovascular outcome among patients with T2DM, but also their quality of life. The Inten-CT study is an investigator-initiated open-label event-driven randomized controlled trial including patients with T2DM stratified according to screen detected coronary artery calcification. The investigators expect inclusion of 7300 patients in 2 years and a mean follow-up period of 5 years.

Conditions

Type 2 Diabetes; Cardiovascular Diseases

Keywords

CVD screening

Outcome Measures

Primary Outcomes (1)

• Rates of a composite cardiovascular endpoint

  Cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, and non-fatal stroke

  Event-driven, expected mean follow-up of 5 years

Secondary Outcomes (5)

• Rates of all-cause mortality and individual components of the primary outcome

  Event-driven, expected mean follow-up of 5 years

• Patient reported outcomes 1

  Change from baseline to End of Study (Event-driven, expected mean follow-up of 5 years)

• Patient reported outcomes 2

  Change from baseline to End of Study (Event-driven, expected mean follow-up of 5 years)

• Patient reported outcomes 3

  Change from baseline to End of Study (Event-driven, expected mean follow-up of 5 years)

• Cost-effectiveness

  Event-driven, expected mean follow-up of 5 years

Other Outcomes (5)

• Treatment with prespecified drugs

  Event-driven, expected mean follow-up of 5 years

• Cardiovascular risk markers 1

  Event-driven, expected mean follow-up of 5 years

• Cardiovascular risk markers 2

  Event-driven, expected mean follow-up of 5 years

Study Arms (2)

CAC-based treatment

EXPERIMENTAL

Patients randomized to CAC-based treatment, will be stratified into low- or high-risk patients (defined by CAC score=0 or ≥ 100), and hence, allocated to two parallel l clinical studies. High-risk patients (CAC≥ 100) in the CAC-based treatment group will be included in a study in which they will receive information on CAC-score, mandatory treatment with dapagliflozin and semaglutide (both study drugs), and advise on further multifactorial treatment of blood lipid levels, blood pressure and antithrombotic therapy. Low-risk patients (CAC=0) will be included in a study in which they will receive information on CAC-score and advise on how multifactorial treatment may be de-intensified.

Other: CAC-based treatment strategy

Standard treatment

OTHER

Patients randomized to standard treatment and their primary physician are not informed about the screening findings. Patients are encouraged to follow contemporary diabetes guidelines at the time of inclusion. This information will be given in a written letter within a week of randomization.

Other: Standard treatment

Interventions

CAC-based treatment strategy OTHER

The intervention is a combination of screening with a heart CT scan and multifactorial intervention based on the screening results. Participants randomized to CAC-based treatment and with screening results showing high risk of CVD, will receive a multifactorial intervention including the combination of two open label investigational medical products: dapagliflozin 10mg/day and semaglutide 0.25 /week or 0.5 /week or 1.0 /week.

CAC-based treatment

Standard treatment OTHER

Participants randomized to standard treatment are recommended to follow updated guidelines for CVD prevention.

Standard treatment

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New or former diagnosis of Type 2 diabetes according to WHO.
• Age between 55-69 years (men) and 60-74 years (women).
• Signed declaration of consent

You may not qualify if:

• Previous history of CVD (previous myocardial infarction or coronary intervention (percutaneous coronary intervention or by-pass), heart failure, stroke or peripheral artery disease as documented by the patient or the patient medical record).
• Contraindications or allergies to both SGLT2 inhibitors and GLP-1 analogues.
• Signs of critical cardiac disease: \>50% stenosis of left main coronary artery (CT angiography) or left ventricular ejection fraction below 30% (echocardiography). If a CT angiography is not available, a CAC\>1000 on the non-contrast cardiac CT will be considered equal to critical cardiac disease.
• Expected life duration \< 1 year for any reason.

Sponsors & Collaborators

• Per Løgstrup Poulsen: lead
• Odense University Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (1)

• Funck KL, Borregaard B, Egstrup K, Fredslund EK, Hansen TW, Kallestrup P, Olsen MH, Reventlow S, Rossing P, Sandbaek A, Sondergaard J, Thomsen JL, Vestergaard P, Poulsen PL, Diederichsen A. Study protocol for the investigator-initiated Danish pragmatic randomised STENO INTEN-CT trial: does screening and intervention for subclinical coronary artery disease in type 2 diabetes reduce cardiovascular events? BMJ Open. 2025 Dec 15;15(12):e106018. doi: 10.1136/bmjopen-2025-106018.

  PMID: 41401988 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Per L Poulsen, Professor

  Steno Diabetes Center Aarhus, AUH, and Aarhus University

  PRINCIPAL INVESTIGATOR

• Axel Diederichsen, Professor

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian L Funck, MD PhD

CONTACT

+4561331588; klf@clin.au.dk

Per L Poulsen, Professor

CONTACT

perpouls@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants are masked for screening results if they are randomized to "standard treatment", but all participants will obtain information on which arm they are randomized.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The Steno Inten-CT study is an investigator-initiated pragmatic open-label event-driven randomized controlled trial.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 26, 2023
• Study Start: January 12, 2023
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: TBA
• Access Criteria: TBA

Locations

DK (1)