Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
618
Countries
6
Sites
49
Chronic Kidney Disease, Type 2 diabetes
To investigate whether CagriSema CCI versus the monocomponents and placebo improve surrogate markers of chronic kidney disease progression in participants with type 2 diabetes living with overweight or obesity.
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify, Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 19 Apr 2024 → 7 Nov 2025
- Decision date (initial)
- 2024-04-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk A/S
External identifiers
- EU CT number
- 2023-505857-42-00
- WHO UTN
- U1111-1291-5907
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To investigate whether CagriSema CCI versus the monocomponents and placebo improve surrogate markers of chronic kidney disease progression in participants with type 2 diabetes living with overweight or obesity.
Secondary objectives 1
- To compare the effect of CagriSema CCI versus the monocomponents and placebo with respect to weight related parameters, glycaemic control, blood pressure and safety and tolerability related parameters.
Conditions and MedDRA coding
Chronic Kidney Disease, Type 2 diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
| 24.1 | PT | 10033307 | Overweight | 100000004861 |
| 23.1 | PT | 10064848 | Chronic kidney disease | 100000004857 |
| 21.1 | LLT | 10045242 | Type II diabetes mellitus | 10027433 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Male or female aged 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- BMI ≥ 27.0 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.
- HbA1c ≤ 10.5% (91 mmol/mol) as assessed by central laboratory at screening.
- Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 mL/min/1.73 m2 (measured with CKD-EPI 2021) as assessed by central laboratory at screening.
- Albuminuria defined by UACR ≥ 100 and < 5000 mg/g as assessed by central laboratory at screening.
- Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.
Exclusion criteria 23
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Participation (i.e., signed informed consent) in any other interventional clinical study within 60 days before screening.
- Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
- Use of any GLP-1 receptor agonist (including medication with GLP-1RA activity, e.g., GIP/GLP-1RA) or amylin analogue within 60 days prior to screening.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 60 days before screening.
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
- Planned coronary, carotid, or peripheral artery revascularisation.
- Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.
- A prior solid organ transplant or awaiting solid organ transplant.
- Combination use of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin II receptor blocker (ARB) 30 days or less prior to screening.
- Initiation of treatment with non-steroidal mineralocorticoid receptor agonist (ns-MRA) or SGLT2 inhibitor less than 30 days prior to screening or change of dose of ongoing treatment with ns-MRA or SGLT2 inhibitor.
- Dose change of ongoing treatment with mineralocorticoid receptor agonist (MRA) or SGLT2 inhibitor less than 30 days prior to screening.
- Acute pancreatitis within 180 days prior to screening.
- History of chronic pancreatitis.
- Any episodes of diabetic ketoacidosis within 90 days before screening
- Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator
- Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question 8.
- Treatment with any medication for the indication of obesity within 90 days before screening.
- Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening.
- Use of any medication with unknown or unspecified content within 90 days before screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in UACR from baseline to end of treatment
Secondary endpoints 13
- Change in eGFR (creatinine and cystatin C-based CKD-EPI 2021) from baseline to end of treatment
- Change in eGFR (creatinine-based CKD-EPI 2021) from baseline to end of treatment
- Relative change in body weight from baseline to end of treatment
- Achievement of ≥ 5 % weight reduction from baseline to end of treatment
- Achievement of ≥ 10 % weight reduction from baseline to end of treatment
- Change in waist circumference from baseline to end of treatment
- Change in glycated haemoglobin (HbA1c) from baseline to end of treatment
- Change in systolic blood pressure from baseline to end of treatment
- Change in diastolic blood pressure from baseline to end of treatment
- Number of treatment emergent adverse events (TEAEs) from baseline to end of treatment
- Number of treatment emergent serious adverse events (SAEs) from baseline to end of treatment
- Number of clinically significant hypoglycaemic episodes (level 2) (BG <3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline to end of treatment
- Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold from baseline to end of treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD8977529 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977527 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977528 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977531 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977530 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 10
PRD8977521 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977520 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977519 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977518 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977517 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977522 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977523 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977525 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977526 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977524 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- 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
Auxiliary 3
SCP54959918 · ATC
- Active substance
- Finerenone
- Substance synonyms
- BAY 94-8862
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA05 — FINERENONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129505 · ATC
- Active substance
- Enalapril Maleate
- Substance synonyms
- Enalapril hydrogen maleate
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09AA02 — ENALAPRIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP153584 · ATC
- Active substance
- Dapagliflozin Propanediol
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — DAPAGLIFLOZIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| 4G Clinical B.V. ORG-100044721
|
Amsterdam, Netherlands | Other |
| SYRINX Bioanalytics Oy ORG-100021026
|
Turku, Finland | Other |
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Assen, Netherlands | Other |
| Abbott GmbH ORG-100000219
|
Wiesbaden, Germany | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Celerion Switzerland AG ORG-100013062
|
Fehraltorf, Switzerland | Other |
| Oracle Danmark ApS ORG-100044663
|
Hellerup, Denmark | Other |
| Oracle America Inc. ORG-100039874
|
Redwood City, United States | Other |
| Nordic Bioscience A/S ORG-100009315
|
Herlev, Denmark | Other |
Locations
6 EU/EEA countries · 49 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 30 | 7 |
| Greece | Ended | 90 | 10 |
| Hungary | Ended | 65 | 7 |
| Poland | Ended | 50 | 12 |
| Slovakia | Ended | 35 | 6 |
| Spain | Ended | 38 | 7 |
| Rest of world
Brazil, Thailand, India, Japan, United States, Canada, Argentina
|
— | 310 | — |
Investigational sites
Centre De Recherche Clinique Portes Du Sud
N/A, 2 Avenue Du 11 Novembre 1918, 69200, Venissieux
Groupe Sos Sante
N/A, 175 Rue Marechal Foch, 71200, Le Creusot
Centre Hospitalier Universitaire Reims
N/A, 45 Rue Cognacq Jay, 51092, Reims Cedex
Centre Hospitalier Universitaire De Nantes
N/A, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Poitiers
N/A, 2 Rue De La Miletrie, 86000, Poitiers
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
N/A, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
Centre Hospitalier Universitaire De Toulouse
N/A, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
General Hospital Of Thessloniki G Gennimatas
Pathology Clinic - Diabetes Outpatient Department, Ethnikis Aminis 41, 546 35, Thessaloniki
Athens Medical Center S.A.
Diabetes department and Clinical Research Center, Areos 36, 175 62, Paleo Faliro
General Hospital Of Athens G Gennimatas
Department of Endocrinology, Messogion Avenue 154, 115 27, Athens
University General Hospital Of Heraklion
Nephrology clinic, Stavrakia And Voutes, 715 00, Heraklion
Laiko General Hospital Of Athens
1st Dpt. of Propaedeutic Internal Medicine - Endocrinology Department, Agiou Thoma (goudi) 17, 115 27, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
A' Department of Internal Medicine - Diabetes department, Exochi, 570 10, Thessaloniki
General University Hospital Of Patras
Nephrology clinic, Rio, 265 04, Patras
Laiko General Hospital Of Athens
1st Propaedeutic clinic of Internal Medicine - Diabetes Department, Agiou Thoma (goudi) 17, 115 27, Athens
Hippokration Hospital
B' Internal Medicine Clinic - Diabetology Center, Konstadinoupoleos 49, 546 42, Thessaloniki
Ippokratio General Hospital Of Thessaloniki
2nd Internal Medicine Clinic, Konstadinoupoleos 49, 546 42, Thessaloniki
Lausmed Kft.
N/A, Fulep Lajos Utca 15, 6500, Baja
Szent Margit Rendelointezet Nonprofit Kft.
Diabetology, Vorosvari Ut 88-96/III, III Kerulet, Budapest III
Borbanya Praxis Egeszsegugyi Kft.
N/A, Bazsalikom Utca 1/1, Borbanya, Nyiregyhaza
University Of Pecs
2nd Department of Internal Medicine and Nephrological Center, Pacsirta Utca 1, 7624, Pecs
Bekes Varmegyei Koezponti Korhaz
N/A, Semmelweis Utca 1, 5700, Gyula
Belinus Bt.
N/A, Erzsebet Utca 11-13, 4025, Debrecen
Siofoki Korhaz-Rendelointezet
Diabetology Clinic, Semmelweis Utca 1, 8600, Siofok
Pratia S.A.
N/A, Ul. Dabrowki 13, 40-081, Katowice
Gaja Poradnie Lekarskie
N/A, os. Orla Bialego 103, 61-251, Poznan
Centrum Medyczne Oporow
N/A, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Kresmed Sp. z o. o.
N/A, Ul. Waska 15a, 15-481, Bialystok
Pratia S.A.
N/A, Ul. Chrzanowskiego 3 Lok 5, 81-338, Gdynia
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii, Ul. Woloska 137, 02-507, Warsaw
M2M Med. Sp. z o.o. Sp. j.
N/A, Ul. Lwowska 34, 41-500, Chorzow
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
N/A, Ul. 3 Maja 13/15, 41-800, Zabrze
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny
N/A, Ul. Ludwika Zamenhofa 10/20, 15-435, Bialystok
Gabinet Lekarski Malgorzata Saryusz-Wolska
N/A, ul. Tramwajowa 19, 90-132, Lodz
Zdrowie Osteo-Medic SC.
N/A, Wiejska 81, 15-351, Bialystok
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
N/A, Ul. 1 Maja 13 C, 10-117, Olsztyn
Kardio-Sanus spol. s r.o.
Kardiologicka ambulancia, Stefana Kralika 1 B, 841 07, Devinska Nova Ves
Medispektrum s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Gercenova 4/a, 851 01, Petrzalka
Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Strojarenska 13, 040 01, Kosice
Univerzitna nemocnica L. Pasteura Kosice
IV. interna klinika, Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Rastislavova 43, Juh, Kosice
Human-Care s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Rastislavova 45, 040 01, Kosice 1
Tatratrial s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Namestie 1. Maja 11, 048 01, Roznava
Hospital Universitario Puerta De Hierro De Majadahonda
N/A, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital General Universitario Gregorio Maranon
N/A, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Fundacion Alcorcon
N/A, Calle Budapest 1, 28922, Madrid
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
N/A, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Bellvitge University Hospital
N/A, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Clinico Universitario De Valencia
N/A, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario De Canarias
N/A, Calle Ofra Sn La Cuesta, 38320, La Laguna
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 |
|---|---|---|---|---|---|
| France | 2024-04-25 | 2025-11-04 | 2024-06-03 | 2025-03-27 | |
| Greece | 2024-05-10 | 2025-11-06 | 2024-05-20 | 2025-03-27 | |
| Hungary | 2024-04-19 | 2025-10-21 | 2024-04-22 | 2025-03-18 | |
| Poland | 2024-04-23 | 2025-10-16 | 2024-05-08 | 2025-03-06 | |
| Slovakia | 2024-04-23 | 2025-10-29 | 2024-04-25 | 2025-03-19 | |
| Spain | 2024-05-13 | 2025-11-06 | 2024-05-27 | 2025-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 63 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_nn9388-7700-protocol-2023-505857-42-english_for-publication | 4 |
| Protocol (for publication) | d1_nn9388-7700-protocol-2023-505857-42-greek_for-publication | 4 |
| Protocol (for publication) | D4-NN9388-7700- Subject Diary- English- For publication | 1 |
| Protocol (for publication) | D4-NN9388-7700- Subject Diary- French- For publication | 1.1 |
| Protocol (for publication) | D4-NN9388-7700- Subject Diary- Greek- For publication | 1 |
| Protocol (for publication) | D4-NN9388-7700- Subject Diary- Hungarian- For publication | 1 |
| Protocol (for publication) | D4-NN9388-7700- Subject Diary- Polish- For publication | 1 |
| Protocol (for publication) | D4-NN9388-7700- Subject Diary- Slovak- For publication | 1 |
| Protocol (for publication) | D4-NN9388-7700- Subject Diary- Spanish- For publication | 1 |
| Protocol (for publication) | Revised transparency_blank document | 1 |
| Recruitment arrangements (for publication) | K1_ES NN9388-7700-Recruitment and Informed Consent Procedure-For publication | 1 |
| Recruitment arrangements (for publication) | K1_FR_NN9388-7700 Recruitment and Informed Consent Procedure_For publication | 1.1 |
| Recruitment arrangements (for publication) | K1_GR-NN9388-7700-Recruitment Arrangements and Informed consent_For Publication | 1 |
| Recruitment arrangements (for publication) | K1_HU_NN9388-7700 Recruitment and Informed Consent Procedure_For publication | 1 |
| Recruitment arrangements (for publication) | K1_PL NN9388-7700-Recruitment and Informed Consent Procedure-For publication | 2.0 |
| Recruitment arrangements (for publication) | K1_SK-NN9388-7700-Recruitment Arrangements and Informed consent_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_ES_NN9388-7700 Recruitment Material Clinical Website Sample Guide_Spanish_For publication | 1 |
| Recruitment arrangements (for publication) | K2_ES_NN9388-7700 Recruitment Material Guidance for text Message Template_Spanish_For publication | 1 |
| Recruitment arrangements (for publication) | K2_FR_NN9388-7700 Advertisement Recruitment Poster_For publication | 2 |
| Recruitment arrangements (for publication) | K2_GR _NN9388-7700_Recruitment material Participants Brochure_Greek_For publication | 2 |
| Recruitment arrangements (for publication) | K2_GR_NN9388-7700_Recruitment material Clinical Website Sample Guide and Text_Greek_For publication | 2 |
| Recruitment arrangements (for publication) | K2_GR_NN9388-7700_Recruitment material Guidance for text Message Template_Greek_For publication | 3 |
| Recruitment arrangements (for publication) | K2_GR-NN9388-7700-Advertisement recruitment poster_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_HU_NN9388-7700 Advertisement Recruitment Poster_For publication | 3 |
| Recruitment arrangements (for publication) | K2_HU_NN9388-7700 Recruitment material Clinical Website Text_Hungarian_For publication | 2 |
| Recruitment arrangements (for publication) | K2_HU_NN9388-7700 Recruitment material Participant brochure_Hungarian_For publication | 2 |
| Recruitment arrangements (for publication) | K2_PL NN9388-7700-Patient Recruitment Advertisement-Recruitment Poster-Polish-For publication | 1 |
| Recruitment arrangements (for publication) | K2_PL_NN9388-7700 Recruitment Material Clinical Website Sample Guide_Polish_For publication | 1 |
| Recruitment arrangements (for publication) | K2_PL_NN9388-7700 Recruitment Material Guidance for text Message Template_Polish_For publication | 1 |
| Recruitment arrangements (for publication) | K2_PL_NN9388-7700 Recruitment Material Participation Brochure_Polish_For publication | 1 |
| Recruitment arrangements (for publication) | K2_SK_NN9388-7700 Recruitment material Clinical Website Sample Guide_Slovak_For publication | 1 |
| Recruitment arrangements (for publication) | K2_SK_NN9388-7700 Recruitment material Guidance for text Message Template_Slovak_For publication | 1 |
| Recruitment arrangements (for publication) | K2_SK_NN9388-7700 Recruitment material Participants Brochure_Slovak_For publication | 1 |
| Recruitment arrangements (for publication) | K2_SK-NN9388-7700-Advertisement recruitment poster_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_ES NN9388-7700 SI-IC-Adult-For publication | 4 |
| Subject information and informed consent form (for publication) | L1_ES NN9388-7700 SI-IC-Future research-For publication | 2 |
| Subject information and informed consent form (for publication) | L1_ES NN9388-7700 SI-IC-Male Partner-For publication | 1 |
| Subject information and informed consent form (for publication) | L1_FR_NN9388-7700 SI-IC Future research_For publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_FR_NN9388-7700 SI-IC Main Adult_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_FR_NN9388-7700 SI-IC Male partner_For publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_GR NN9388-7700-SI-IC Future Research-For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_GR NN9388-7700-SI-IC Main-For Publication | 3 |
| Subject information and informed consent form (for publication) | L1_GR NN9388-7700-SI-IC Male-For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_HU_NN9388-7700 SI-IC Future research_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_HU_NN9388-7700 SI-IC genetic testing_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_HU_NN9388-7700 SI-IC Main Adult_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_HU_NN9388-7700 SI-IC Male partner_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_PL NN9388-7700 SI-IC-Future Research-For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_PL NN9388-7700 SI-IC-Male-For publication | 2.0 |
| Subject information and informed consent form (for publication) | l1_pl-nn9388-7700-piic-main_Polish_for-publication | 5 |
| Subject information and informed consent form (for publication) | L1_SK NN9388-7700-SI-IC Data Protection-For Publication | 3 |
| Subject information and informed consent form (for publication) | L1_SK NN9388-7700-SI-IC Future Research-For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SK NN9388-7700-SI-IC Main Adult-For Publication | 4 |
| Subject information and informed consent form (for publication) | L1_SK NN9388-7700-SI-IC Male Partner-For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_HU_NN9388-7700- Participant ID Card- For publication | 2 |
| Synopsis of the protocol (for publication) | D1-NN9388-7700- Protocol Synopsis NOT for lay person-HU-EU CT 2023-505857-42-00-For publication | 1 |
| Synopsis of the protocol (for publication) | D1-NN9388-7700- Protocol Synopsis-ENG-EU CT 2023-505857-42-00-For publication | 1 |
| Synopsis of the protocol (for publication) | D1-NN9388-7700- Protocol Synopsis-ES-EU CT 2023-505857-42-00-For publication | 1 |
| Synopsis of the protocol (for publication) | D1-NN9388-7700- Protocol Synopsis-FR-EU CT 2023-505857-42-00-For publication | 1 |
| Synopsis of the protocol (for publication) | D1-NN9388-7700- Protocol Synopsis-GR-EU CT 2023-505857-42-00-For publication | 1 |
| Synopsis of the protocol (for publication) | D1-NN9388-7700- Protocol Synopsis-HU-EU CT 2023-505857-42-00-For publication | 1 |
| Synopsis of the protocol (for publication) | D1-NN9388-7700- Protocol Synopsis-PL-EU CT 2023-505857-42-00-For publication | 1 |
| Synopsis of the protocol (for publication) | D1-NN9388-7700- Protocol Synopsis-SK-EU CT 2023-505857-42-00-For publication | 1 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-04 | Slovakia | Acceptable 2024-04-15
|
2024-04-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-24 | Slovakia | Acceptable 2024-04-15
|
2024-04-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-10 | Slovakia | Acceptable | 2024-07-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-10 | Acceptable | 2024-07-15 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-10 | Acceptable | 2024-07-08 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-10 | Acceptable | 2024-07-22 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-06-10 | Acceptable | 2024-09-12 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-06-10 | Acceptable | 2024-07-26 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-21 | Slovakia | Acceptable 2025-01-03
|
2025-01-03 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-03-06 | Slovakia | Acceptable 2025-06-04
|
2025-06-04 |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-08-20 | Slovakia | Acceptable 2025-09-30
|
2025-09-30 |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-11-10 | Acceptable | 2026-01-13 |