Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
7,300
Countries
1
Sites
12
Type 2 diabetes
In type 2 diabetes patients and no known cardiovascular disease, we aim to evaluate the possible cardiovascular benefit of a treatment strategy based on a heart CT scan.
Key facts
- Sponsor
- Aarhus University Hospital, Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 12 Jan 2023 → ongoing
- Decision date (initial)
- 2022-07-08
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- the Danish Regions · Novo Nordisk Foundation · AstraZeneca · the Danish Diabetes Association · Novo Nordisk A/S
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
In type 2 diabetes patients and no known cardiovascular disease, we aim to evaluate the possible cardiovascular benefit of a treatment strategy based on a heart CT scan.
Secondary objectives 5
- to investigate the patient-reported outcomes of a screening and treatment program based on a heart CT scan.
- to calculate the cost-effectiveness of the proposed screening and treatment program.
- to evaluate and compare the use of diagnostic tests and therapeutic interventions caused by the proposed screening program.
- to investigate if coronary CT angiography and echocardiography add supplementary information on prognosis and treatment response beyond that provided by the proposed screening with CAC score.
- to evaluate novel biomarkers of subclinical cardiovascular damage that may add information on prognosis and treatment response beyond that provided by the proposed screening with CAC score.
Conditions and MedDRA coding
Type 2 diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067585 | Type 2 diabetes mellitus | 100000004861 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-500143-21-00 | Screening and intervention for subclinical coronary artery disease in patients with type 2 diabetes: THE STENO INTEN-CT STUDY | Aarhus University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- New or former diagnosis of T2DM according to WHO.
- Age between 55-69 years (men) and 60-74 years (women).
- Signed declaration of consent
Exclusion criteria 4
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Rates of a composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, non-fatal stroke and revascularization of peripheral artery disease).
Secondary endpoints 3
- Separate cardiovascular endpoints, all-cause mortality, and renal failure.
- Patient reported outcomes (EQ-5D questionnaire)
- Quality adjusted life years (QALY) using data from the EQ-5D questionnaire and Danish preference weights of the normal population. Register-based rates of procedural codes encompassing tests for atherosclerosis/ischemia of the heart, brain or peripheral circulation and register-based rates of prescription of drugs used in CVD prophylaxis (glucose-lowering drugs, antihypertensive drugs, lipid-lowering drugs and antithrombotic drugs).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Ozempic 0.5 mg solution for injection in pre-filled pen
PRD6392563 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.14 mg milligram(s)
- Max total dose
- 0.14 mg milligram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/004
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ozempic 0.25 mg solution for injection in pre-filled pen
PRD6392561 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.14 mg milligram(s)
- Max total dose
- 0.14 mg milligram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/002
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ozempic 1 mg solution for injection in pre-filled pen
PRD6392569 · Product
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 0.14 mg milligram(s)
- Max total dose
- 269 mg milligram(s)
- Max treatment duration
- 59 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/005
- MA holder
- NOVO NORDISK A/S
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Forxiga 10 mg film-coated tablets
PRD2427550 · Product
- Active substance
- Dapagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 16800 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — -
- Marketing authorisation
- EU/1/12/795/009
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 5
Iomeron 350 mg I/ml injektionsvätska, lösning
PRD2260911 · Product
- Active substance
- Iomeprol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 250 ml millilitre(s)
- Max total dose
- 250 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08AB10 — IOMEPROL
- Marketing authorisation
- 13214
- MA holder
- BRACCO IMAGING S.P.A.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray.
PRD6003577 · Product
- Active substance
- Glyceryl Trinitrate
- Substance synonyms
- TRINITRIN, GLONOINUM, 1,3-DINITROOXYPROPAN-2-YL NITRATE, GLYCEROL TRINITRATE, TRINITROGLYCERIN, NITROGLYCERIN (GLYCERYL TRINITRATE), GTN, NITROGLYCEROL, GLYCERYL-TRINITRATE, NITROGLYCERIN
- Pharmaceutical form
- SUBLINGUAL SPRAY
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 3 DF dosage form
- Max total dose
- 3 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01DA02 — GLYCERYL TRINITRATE
- Marketing authorisation
- PA2243/001/001
- MA holder
- G. POHL-BOSKAMP GMBH CO. KG
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Atenolol Orifarm 50 mg tabletter
PRD331251 · Product
- Active substance
- Atenolol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07AB03 — ATENOLOL
- Marketing authorisation
- 10910
- MA holder
- ORIFARM GENERICS A/S
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Seloken 1 mg/ml injektionsvätska, lösning
PRD395583 · Product
- Active substance
- Metoprolol Tartrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 15 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07AB02 — METOPROLOL
- Marketing authorisation
- 41601
- MA holder
- ASTRAZENECA AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ivabradin Medical Valley 5 mg filmdragerade tabletter
PRD5678613 · Product
- Active substance
- Ivabradine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 15 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01EB17 — -
- Marketing authorisation
- 53687
- MA holder
- MEDICAL VALLEY INVEST AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University Hospital
- Sponsor organisation
- Aarhus University Hospital
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Per Løgstrup Poulsen
Public contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Per Løgstrup Poulsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Institut For Klinisk Medicin Aarhus Universitet ORG-100026606
|
Aarhus N, Denmark | On site monitoring |
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Axel Cosmus Pyndt Diederichsen
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Axel Cosmus Pyndt Diederichsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, Code 8 |
Sponsor responsibilities
- Article 77 compliance
- Aarhus University Hospital
- Contact point sponsor
- Aarhus University Hospital
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 7,300 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Odense University Hospital
Dep of Cariology, Baagoees Alle 15, 5700, Svendborg
Aalborg University Hospital
Steno Diabetes Center Nordjylland, Hobrovej 18/22, 9000, Aalborg
Nordsjaellands Hospital
Endocrinology and Nephrology, Dyrehavevej 29, 3400, Hilleroed
Sydvestjysk Sygehus
Department of Medicine, Finsensgade 35, 6700, Esbjerg
Holbaek Sygehus
Internal Medicine, Smedelundsgade 60, 4300, Holbæk
Steno Diabetes Center Copenhagen
Steno Diabetes Center Copenhagen, Borgmester Ib Juuls Vej 83, 2730, Herlev
Odense University Hospital
Department of Cardiology, J B Winsloews Vej 4, 5000, Odense C
Aarhus University Hospital
Steno Diabetes Center Aarhus, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Midtjylland
Diagnostisk Center, Falkevej 1/3, 8600, Silkeborg
Nykoebing F Sygehus
Dep of Cardiology, Fjordvej 15, 4800, Nykobing F
Lillebaelt Hospital
Department of Cardiology, Sygehusvej 24, 6000, Kolding
Region Midtjylland
Department of Internal Medicine and Endocrinology, Hospitalsparken 15, 7400, Herning
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-01-12 | 2023-01-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Appendix E_Deltagerinformation_INTEN-CT | 1 |
| Subject information and informed consent form (for publication) | Appendix E_Deltagerinformation_INTEN-CT_TR | 1 |
| Subject information and informed consent form (for publication) | Appendix E_Deltagerinformation_INTEN-CT_Tracked changes | 1 |
| Subject information and informed consent form (for publication) | Appendix F_Samtykkeerklring_INTEN-CT | 1 |
| Subject information and informed consent form (for publication) | Appendix F_Samtykkeerklring_INTEN-CT_Ver1_1_tracked changes | 1 |
| Subject information and informed consent form (for publication) | Appendix G_ Brevsvar til patient og lge_ INTEN-CT | 1 |
| Subject information and informed consent form (for publication) | Appendix G_ Brevsvar til patient og lge_ INTEN-CT_TR | 1 |
| Subject information and informed consent form (for publication) | Appendix G_ Brevsvar til patient og lge_ INTEN-CT_Tracked Changes | 1 |
| Subject information and informed consent form (for publication) | Appendix H_Henvendelsesbrev_INTEN-CT | 1 |
| Subject information and informed consent form (for publication) | Appendix I_Visual bilag til deltagerinformation | 1 |
| Subject information and informed consent form (for publication) | Appendix K_Deltagerinformation og samtykke biobank_INTEN-CT | 1 |
| Subject information and informed consent form (for publication) | Appendix K_Deltagerinformation og samtykke biobank_INTEN-CT_ver1_tracked changes | 1 |
| Subject information and informed consent form (for publication) | INTEN-CT - Substudy no1_participant information and signed consent form | 1 |
| Subject information and informed consent form (for publication) | INTEN-CT - Substudy no1_questionnaire | 1 |
| Subject information and informed consent form (for publication) | Questionnaire_PHQ9_Danish for Denmark | 1 |
| Subject information and informed consent form (for publication) | Questionnarie_GAD7_Danish for Denmark | 1 |
| Subject information and informed consent form (for publication) | Social Media announcement_INTEN-CT_ver1 | 1 |
| Subject information and informed consent form (for publication) | Sprgeskema_INTEN-CT | 1 |
| Subject information and informed consent form (for publication) | Survey_INTEN-CT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Product-information Ozempic | 1 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-05-20 | Denmark | Acceptable 2022-07-04
|
2022-07-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2022-12-07 | Denmark | Acceptable 2022-07-04
|
2022-12-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-03 | Denmark | Acceptable | 2023-05-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-05-15 | Denmark | Acceptable 2023-07-05
|
2023-07-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-08-29 | Denmark | Acceptable | 2023-10-30 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-12-04 | Denmark | Acceptable 2024-01-12
|
2024-01-16 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-02-08 | Denmark | Acceptable | 2024-03-20 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-06-19 | Acceptable 2024-08-15
|
||
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-08-20 | Denmark | Acceptable | 2024-09-20 |