Overview
Sponsor-declared trial summary
Type 2 diabetes
The primary objective is to demonstrate the superiority of the combination of vicadrostat and empagliflozin compared with vicadrostat-placebo and empagliflozin for the time to first CV death, HHF, or urgent HF visit in participants with T2DM, HTN and established CVD.
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 15 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521188-11-00
- WHO UTN
- U1111-1319-9064
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The primary objective is to demonstrate the superiority of the combination of vicadrostat and empagliflozin compared with vicadrostat-placebo and empagliflozin for the time to first CV death, HHF, or urgent HF visit in participants with T2DM, HTN and established CVD.
Conditions and MedDRA coding
Type 2 diabetes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- At least 18 years old at time of consent
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male or female participants. WOCBP (see Section 4.2.2.3) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
- Participants with medical history of hypertension and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator)
- Participants with medical history of T2DM and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator)
- Established CV disease and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator).
- At least one additional risk factor for developing HF
Exclusion criteria 7
- History of HF or hospitalization for HF or treatment of HF
- Atrial fibrillation or Atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1 (screening)
- Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
- Treatment with an MRA
- Treatment with amiloride or other potassium-sparing diuretic
- Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial: o A direct renin inhibitor (e.g. aliskiren) o More than one ACEi and/or ARB (including ARNi) used simultaneously o Other aldosterone synthase inhibitors (e.g. baxdrostat) o Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone)
- Further exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to first event of CV death or HFE (defined as HHF or urgent HF visit)
Secondary endpoints 13
- Time to first event of CV death or HHF
- Absolute change from baseline in mean SBP [mmHg] at Week 24
- Relative change from baseline in UACR [mg/g] at Week 24
- Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death
- Time to first event of CV death, HFE, non-fatal MI or non-fatal stroke (4-point MACE)
- Occurrences of all-cause hospitalisations (first and recurrent)
- Time to first event of new-onset atrial fibrillation or atrial flutter (in participants without history of atrial fibrillation and atrial flutter) or CV death
- Time to all-cause death
- Time to CV death
- Time to first HHF
- Time to first event of new-onset HF or CV death
- Occurrences of HHF (first and recurrent)
- Absolute change from baseline in mean DBP [mmHg] at Week 24
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Jardiance 10 mg film-coated tablets
PRD1594873 · Product
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 15510 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BK03 — -
- Marketing authorisation
- EU/1/14/930/018
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11187391 · Product
- Active substance
- BI 690517
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Other |
| IQVIA RDS Hellas Single Member S.A. ORG-100048380
|
Chalandri, Greece | On site monitoring, Code 12, Other |
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Sponsor responsibilities
- Article 77 compliance
- Boehringer Ingelheim International GmbH
- Contact point sponsor
- Boehringer Ingelheim International GmbH
- Article 77 implementation
- Boehringer Ingelheim International GmbH
Locations
23 EU/EEA countries · 444 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 60 | 7 |
| Belgium | Ongoing, recruiting | 170 | 12 |
| Bulgaria | Authorised, recruiting | 170 | 17 |
| Croatia | Ongoing, recruiting | 50 | 7 |
| Czechia | Ongoing, recruiting | 120 | 12 |
| Denmark | Ongoing, recruiting | 100 | 8 |
| Finland | Ongoing, recruiting | 105 | 9 |
| France | Ongoing, recruiting | 350 | 42 |
| Germany | Ongoing, recruiting | 1,020 | 93 |
| Greece | Ongoing, recruiting | 160 | 17 |
| Hungary | Ongoing, recruiting | 180 | 15 |
| Ireland | Ongoing, recruiting | 46 | 3 |
| Italy | Ongoing, recruiting | 330 | 33 |
| Latvia | Ongoing, recruiting | 68 | 8 |
| Lithuania | Ongoing, recruiting | 60 | 7 |
| Netherlands | Ongoing, recruiting | 220 | 26 |
| Norway | Ongoing, recruiting | 150 | 11 |
| Poland | Ongoing, recruiting | 410 | 28 |
| Portugal | Ongoing, recruiting | 250 | 20 |
| Romania | Ongoing, recruiting | 190 | 25 |
| Slovakia | Ongoing, recruiting | 95 | 8 |
| Spain | Ongoing, recruiting | 220 | 21 |
| Sweden | Ongoing, recruiting | 120 | 15 |
| Rest of world
Hong Kong, China, Serbia, Thailand, Taiwan, Canada, Vietnam, Japan, Korea, Republic of, Malaysia, Mexico, United States, South Africa, New Zealand, Israel, United Kingdom, Philippines, Brazil, Colombia, Saudi Arabia, Singapore, Australia, Chile, Egypt, India, Switzerland, Argentina
|
— | 7,072 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Austria | 2025-10-22 | 2025-11-17 | |||
| Belgium | 2025-10-15 | 2025-10-23 | |||
| Bulgaria | 2025-10-29 | ||||
| Croatia | 2025-11-12 | 2025-11-13 | |||
| Czechia | 2025-11-10 | 2025-12-17 | |||
| Denmark | 2025-10-17 | 2025-11-21 | |||
| Finland | 2025-11-25 | 2025-11-27 | |||
| France | 2025-10-15 | 2025-10-16 | |||
| Germany | 2025-10-15 | 2025-10-21 | |||
| Greece | 2026-01-13 | 2026-01-28 | |||
| Hungary | 2025-10-30 | 2025-11-10 | |||
| Ireland | 2025-12-15 | 2026-01-14 | |||
| Italy | 2025-11-18 | 2025-11-26 | |||
| Latvia | 2025-11-11 | 2025-11-25 | |||
| Lithuania | 2025-11-11 | 2025-11-27 | |||
| Netherlands | 2025-12-19 | 2026-01-29 | |||
| Norway | 2025-10-21 | 2025-11-05 | |||
| Poland | 2025-10-29 | 2025-10-30 | |||
| Portugal | 2025-10-24 | 2025-10-28 | |||
| Romania | 2025-10-31 | 2025-11-05 | |||
| Slovakia | 2025-10-30 | 2025-11-04 | |||
| Spain | 2025-10-23 | 2025-11-07 | |||
| Sweden | 2025-11-04 | 2025-11-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 406 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2025-521188-11-00-GR-public | 2 |
| Protocol (for publication) | d1_protocol-2025-521188-11-00-public | 2 |
| Protocol (for publication) | d1_protocol-local-amendment-1-2025-521188-11-00-public | 1 |
| Protocol (for publication) | d1_protocol-local-amendment-2-2025-521188-11-00-public | 2 |
| Protocol (for publication) | d1_protocol-synopsis-scientific_2025-521188-11-00-public | 1 |
| Protocol (for publication) | d1_protocol-synopsis-scientific_AT-2025-521188-11-00-public | 1 |
| Protocol (for publication) | d1_protocol-synopsis-scientific_BG-2025-521188-11-00-public | 1 |
| Protocol (for publication) | d1_protocol-synopsis-scientific_CZ-2025-521188-11-00-public | 1 |
| Protocol (for publication) | d1_protocol-synopsis-scientific_EL-2025-521188-11-00-public | 2 |
| Protocol (for publication) | d1_protocol-synopsis-scientific_HU-2025-521188-11-00-public | 1 |
| Protocol (for publication) | d1_protocol-synopsis-scientific_IT-2025-521188-11-00-public | 2 |
| Protocol (for publication) | d1_protocol-synopsis-scientific_RO-2025-521188-11-00-public | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-be | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-bg | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-bg-bul | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-cz | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-de-eng | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-dk | 3 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-el | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-es | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-fi | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-fr | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-hr | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-hu | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-ie | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-it | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-lt | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-lv | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-master-document-hu-public | 3 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-nl | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-no | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-pl | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-pt | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-ro | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-se | 2 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-sk-public | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-study-registry-hu | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-template-at | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-advertisement-clinlife-bg | 3.4 |
| Recruitment arrangements (for publication) | k2_recruitment-clinical-wall-poster-bg | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-information-brochure-bg-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-adshort1-fin009-fi | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-adshort2-fin009-fi | 2 |
| Recruitment arrangements (for publication) | k2_recruitment-material-advertisement-clinic-wall-poster-cz | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-advertisement-clinic-wall-poster-hu | 1.1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-advertisement-clinlife-cz | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-advertisement-de | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-advertisement-information-brochure-hu-public | 1.1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-advertisement-study-flyer-hu-public | 1.1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-advertisement-wall-poster-hr | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-advertising-content-at | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-advertising-content-pl | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-brochure-el-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-brochure-fr-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-brochure-ie-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-brochure-it-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-brochure-lt-lit-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-brochure-lt-rus-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-brochure-lv-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-brochure-pt | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinic-wall-poster-es | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinic-wall-poster-fi | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinic-wall-poster-se | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinical-wall-poster-at | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinical-wall-poster-de | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinical-wall-poster-no | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinical-wall-poster-ro | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinical-wall-poster-sk | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-Clinlife-EC-Notes-ro-eng | 3.4 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinlife-info-EC-at-eng | 3-4 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinlife-info-eng-pl | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinlife-page-at-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-clinlife-pol-pl-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-cts-script-ie | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-at-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-be-dut-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-be-eng-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-be-fre-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-bg-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-cz-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-de-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-el-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-es-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-hr-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-hu-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-ie-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-lt-lit-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-lt-rus-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-no-public | 1-1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-no-track-changes | 1-1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-pl-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-ro-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-se-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-database-letter-sk-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-dtp-outreach-de | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-epr-participant-journey-emails-bg | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-flyer-el-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-flyer-fr-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-flyer-ie-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-flyer-it-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-flyer-lt-lit-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-flyer-lt-rus-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-flyer-lv-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-flyer-pt-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-illustrations-dut-be | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-illustrations-fin009-fi | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-info-brochure-de-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-information-brochure-pl-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-langland-nl | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-langland-tcert-lt | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-letter-it-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-linkedin-easi-protk-studies-de | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-magazine-fi-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-master-document-bg-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-master-document-cz-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-moa-patient-video-transcript-hr-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-mode-of-action-video-script-at | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-outreach-advertising-bg | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-participant-journey-at | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-participant-journey-email-de-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-participant-journey-pl | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-brochure-dut-be-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-brochure-eng-be-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-brochure-fre-be-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-brochure-no-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-brochure-ro-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-database-letter-lv-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-info-brochure-at-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-info-brochure-fi-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-info-brochure-lv-rus-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-info-brochure-sk-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-information-brochure-cz-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-information-brochure-es-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-information-brochure-hr-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-patient-information-brochure-se-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-poster-el | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-poster-fr | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-poster-lv | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-poster-pl | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-poster-pt | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-pre-screening-web-content-bg | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-pre-screening-web-pl | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-pre-screening-website-at | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-pre-screening-website-de-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-recruitment-plan-dut-be-public | 2 |
| Recruitment arrangements (for publication) | k2_recruitment-material-recruitment-slogans-dut-be | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-recruitment-text-1-de | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-recruitment-text-2-de | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-recruitment-text-deu049-de | 1-3 |
| Recruitment arrangements (for publication) | k2_recruitment-material-script-cz | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-script-el | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-script-pt | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-script-video-es | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-social-media-campaign-nl-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-details-page-ro-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-at-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-cz-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-de-not-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-es-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-fi-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-hr-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-no-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-pl-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-ro-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-se-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-study-flyer-sk-public | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-type-02-diabetes-de | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-video-script-at | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-video-script-be-dut | 1 |
| Recruitment arrangements (for publication) | k2_recruitment-material-video-script-be-eng | 1 |
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| Subject information and informed consent form (for publication) | l2_other-subject-information-flipchart-hu-public | 2 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-flipchart-ie-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-flipchart-it-public | 1 |
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| Subject information and informed consent form (for publication) | l2_other-subject-information-flipchart-lt-rus-public | 1 |
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| Subject information and informed consent form (for publication) | l2_other-subject-information-flipchart-pt-public | 1 |
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| Subject information and informed consent form (for publication) | l2_other-subject-information-icf-flipchart-lv-rus-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-identification-card-hu | 2-0 |
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| Subject information and informed consent form (for publication) | l2_other-subject-information-material-cover-letter-retention-it | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-flipchart-at-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-flipchart-hr-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-flipchart-lv-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-flipchart-no-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-flipchart-ro-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-flipchart-se-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-flipchart-sk-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-moa-video-cz | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-moa-video-el | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-moa-video-pt | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-moa-video-script-it | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-moa-video-transc-se | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-retention-it-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-video-script-sk | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-no | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-be | 3 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-be-dut | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-be-eng | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-bg | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-de | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-es | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-hu | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-MOA-video-script-ie | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-lt-lit | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-lt-rus | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-lv | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-MOA-video-script-ro | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-russ-lv | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-MOA-video-script-TCert-ie | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-moa-video-script-tcert-lt | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-retention-plan-ie-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-scout-policy-it-public | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-summary-of-changes-main-icf-dk-public | 2-1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-trial-id-card-bg-public | 2 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-trial-identification-card-it | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-video-script-fr-public | 3 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-video-script-pl | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_AT-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_BE-dut-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_BE-fre-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_BE-ger-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_BG-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_CZ-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_DE-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_DK-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_ES-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_FI-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_FR-eng-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_FR-fre-2025-521188-11-00 | 3 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_GR-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_HR-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_HU-2025-521188-11-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_IT-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_LT-lit-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_LT-rus-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_LV-lat-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_LV-rus-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_NL-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_NO-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_PL-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_PT-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_RO-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_SE-2025-521188-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_SK-2025-521188-11-00 | 2 |
Application history
25 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-06 | Germany | Acceptable 2025-09-24
|
2025-09-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-10-10 | Acceptable | 2025-10-24 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-16 | Acceptable | 2026-01-27 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-16 | Acceptable | 2025-12-22 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-16 | Acceptable | 2025-11-06 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-16 | Acceptable | 2026-01-07 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-16 | Acceptable | 2026-01-14 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-16 | Acceptable | 2025-11-27 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-16 | Acceptable | 2025-12-19 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-10-16 | Acceptable | 2025-12-01 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-16 | Germany | Acceptable | 2026-01-12 |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-10-16 | Acceptable | 2025-12-02 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-10-16 | Acceptable | 2025-11-19 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-10-16 | Acceptable | 2025-12-05 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-10-16 | Acceptable | 2025-12-04 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-10-16 | Acceptable | 2025-12-01 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-10-16 | Acceptable | 2026-01-22 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-10-16 | Acceptable | 2025-11-17 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-10-16 | Acceptable | 2025-12-02 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-21 | 2025-10-16 | Acceptable | 2025-11-18 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-22 | 2025-10-16 | Acceptable | 2025-12-05 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-23 | 2025-10-16 | Acceptable | 2026-02-09 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-24 | 2025-10-16 | Acceptable | 2025-12-01 | |
| 24 | SUBSTANTIAL MODIFICATION | SM-25 | 2025-10-16 | Acceptable | 2025-10-21 | |
| 25 | SUBSTANTIAL MODIFICATION | SM-26 | 2026-03-17 | Germany | Acceptable 2026-05-27
|
2026-05-27 |