Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruitment pending
Participants planned
460
Countries
14
Sites
38
Obesity and T2D
To confirm superiority of CagriSema 2.4 mg/2.4 mg s.c. once weekly versus placebo* and/or of Cagrilintide 2.4 mg s.c. once weekly versus placebo on weight management* (tested in parallel)
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2026-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novo Nordisk A/S
External identifiers
- EU CT number
- 2023-509176-42-00
- WHO UTN
- U1111-1299-4751
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacokinetic
To confirm superiority of
CagriSema 2.4 mg/2.4 mg s.c.
once weekly versus placebo*
and/or of Cagrilintide 2.4 mg s.c.
once weekly versus placebo on
weight management* (tested in
parallel)
Secondary objectives 4
- To confirm superiority of CagriSema 2.4 mg/2.4 mg s.c. once weekly versus placebo and/or of cagrilintide 2.4 mg s.c. once weekly versus placebo on weight management (tested in parallel)
- To confirm superiority of CagriSema 2.4 mg/2.4 mg s.c. once weekly versus semaglutide 2.4 mg s.c. once weekly on weight management.
- To confirm superiority of CagriSema 2.4 mg/2.4 mg s.c. once weekly versus placebo on weight management
- To confirm superiority of cagrilintide 2.4 mg s.c. once weekly versus placebo on weight management*
Conditions and MedDRA coding
Obesity and T2D
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-003059-PIP01-21
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study -related activities. Study -related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. a. The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements) b. The child must sign and date the Child Assent Form or provide oral assent (according to local requirements).
- Male or female.
- Aged 8 to <18 years at the time of signing the informed consent.
- Body mass index (BMI), at screening, corresponding to: a. ≥95th percentilea for children aged 8 to <12 years (Tanner stage 1-5) b. ≥95th percentilea or ≥85th percentilea with the presence of at least one obesity-related complication including, but not limited to, type 2 diabetes (T2D), hypertension, dyslipidaemia or obstructive sleep apnoea for adolescents aged 12 to <18 years (Tanner stage 2-5).
- Laboratory parameters, as measured by the central lab at screening, within normal sex- and age-specific ranges of total calcium, phosphate, alkaline phosphatase, parathyroid hormone.
- History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months.
- Body weight >45 kg at screening.
- HbA1c ≤10.0% (86 mmol/mol) as measured by central laboratory at screening.
- Treatment with lifestyle intervention or treatment with metformin according to local label. Treatment with metformin should be stable (same dose and dosing frequency) for at least 56 days before screening.
Exclusion criteria 13
- Treatment with any medication prescribed for obesity or weight management 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: Liposuction and/or abdominoplasty, if performed >1 year before screening. Adjustable gastric banding, if the band has been removed >1 year before screening. Intragastric balloon, if the balloon has been removed >1 year before screening. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year before screening.
- Uncontrolled thyroid disease.
- Endocrine, hypothalamic, or syndromic obesity.
- A self-reported (or by parent(s)/LAR, where applicable) change in body weight >5% within 90 days before screening irrespective of medical records.
- Type 1 diabetes or monogenic diabetes.
- HbA1c ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
- Treatment with glucose -lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire, question 8.
- Recurrent severe hypoglycaemic episodes within 1 year before screening, as judged by the investigator.
- Positive insulinoma associated protein-2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
- Treatment with any medication for the indication of diabetes other than those stated in the inclusion criteria within 90 days before screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Relative change in body mass index (BMI). Baseline (week 0) to end of treatment (week 68). Unit: %.
Secondary endpoints 7
- Relative change in body weight. Baseline (week 0) to end of treatment (week 68). Unit: %.
- Change in BMI Standard Deviation Score (SDS). Baseline (week 0) to end of treatment (week 68). Unit: SDS score
- Relative change in BMI. Baseline (week 0) to end of treatment (week 68). Unit: %.
- Relative change in body weight. Baseline (week 0) to end of treatment (week 68). Unit: %.
- Change in BMI Standard Deviation Score (SDS). Baseline (week 0) to end of treatment (week 68). Unit: SDS score.
- Reduction in weight category. Baseline (week 0) to end of treatment (week 68). Unit: count of participant.
- Reduction in weight category. Baseline (week 0) to end of treatment (week 68). Unit: count of participant.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
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
- 224 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
- 224 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
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
- 224 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
- 224 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
- 224 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
- 224 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
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
- 224 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
- 224 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
- 224 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 5
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
- 68 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
- 68 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
- 68 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
- 68 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
- 68 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
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 11
| Organisation | City, country | Duties |
|---|---|---|
| Wuxi Apptec (Shanghai) Co. Ltd. ORG-100053285
|
Shanghai, China | Other |
| Oracle Danmark ApS ORG-100044663
|
Hellerup, Denmark | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Burlington, United States | Other |
| Synexa Life Sciences BV ORL-000013389
|
Leiden, Netherlands | Other |
| Signant Health Global Solutions Limited ORG-100047290
|
Dublin 2, Ireland | Other |
| 4G Clinical B.V. ORG-100044721
|
Amsterdam, Netherlands | Other |
| Vivos Technology Limited ORG-100041363
|
London, United Kingdom | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Roche Diabetes Care Inc. ORG-100047645
|
Indianapolis, United States | Other |
| Celerion Switzerland AG ORG-100013062
|
Fehraltorf, Switzerland | Other, Laboratory analysis |
Locations
14 EU/EEA countries · 38 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 10 | 2 |
| Belgium | Authorised, recruitment pending | 10 | 2 |
| Bulgaria | Authorised, recruitment pending | 16 | 4 |
| Croatia | Authorised, recruitment pending | 10 | 3 |
| Denmark | Authorised, recruitment pending | 10 | 1 |
| Hungary | Authorised, recruitment pending | 11 | 3 |
| Italy | Authorised, recruitment pending | 11 | 4 |
| Netherlands | Authorised, recruitment pending | 10 | 1 |
| Poland | Authorised, recruitment pending | 18 | 4 |
| Portugal | Authorised, recruitment pending | 10 | 3 |
| Romania | Authorised, recruitment pending | 11 | 3 |
| Slovakia | Authorised, recruitment pending | 10 | 3 |
| Spain | Authorised, recruitment pending | 10 | 3 |
| Sweden | Not authorised | 10 | 2 |
| Rest of world
Colombia, Mexico, Israel, United States, China, Australia, Malaysia, Taiwan, Thailand, United Kingdom, Serbia, India
|
— | 303 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Kinder- und Jugendheilkunde, Anichstrasse 35, 6020, Innsbruck
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Universitätsklinik für Kinder und Jugendheilkunde Haus E, Muellner Hauptstrasse 48, 5020, Salzburg
UZ Brussel
NA, Laarbeeklaan 101, 1090, Jette
Universitair Ziekenhuis Antwerpen
NA, Drie Eikenstraat 655, 2650, Edegem
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Pediatric, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
Children's Health Medical Center EOOD
Consulting room 14, Ulitsa Maestro Kinev 2 A, 1618, Sofia
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev
Clinic of pediatric endocrinology and metabolic diseases, Academician Ivan Geshov Blvd 11, 1606, Sofia
MBAL Sveta Marina EAD
First pediatric clinic, Pediatric department for intensive treatment, Hristo Smirnenski Str 1, 9010, Varna
Clinical Hospital Centre Rijeka
NA, Kresimirova 42, 51000, Rijeka
Klinika Za Djecje Bolesti Zagreb
NA, Ulica Vjekoslava Klaica 16, Zagreb, Grad Zagreb
Klinicki bolnicki centar Sestre milosrdnice
NA, Vinogradska Cesta 29, Zagreb, Grad Zagreb
Eszak-Budai Szent Janos Centrumkorhaz
Észak-Közép-budai Centrum, Szent János Kórház és Szakrendel, Bolyai Utca 5-9, 1023, Budapest II
Semmelweis University
Gyermekgyógyászati Klinika - Bókay utcai részleg, Bokay Janos Utca 53, 1083, Budapest VIII
University Of Szeged
Szegedi Tudományegyetem Gyermekgyógyászati Klinika, Koranyi Fasor 14-15, 6720, Szeged
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
NA, Via Francesco Sforza 28, 20122, Milan
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
NA, Via Dell' Istria 65/1, 34137, Trieste
Azienda Ospedaliero-Universitaria Maggiore Della Carita
NA, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ospedaliera Universitaria Integrata Verona
NA, Piazzale Aristide Stefani 1, 37126, Verona
Jeroen Bosch Ziekenhuis Stichting
NA, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej Im. Dzieci Warszawy W Dziekanowie Lesnym
Kliniczny Oddział Pediatrii, Ul. Marii Konopnickiej 65, Dziekanow Lesny, Lomianki
Uniwersytecki Szpital Kliniczny W Opolu
Oddział Pediatrii z Pododzialem Gastroenterologii i Diabetologii Dzieciecej, Al. Wincentego Witosa 26, 45-401, Opole
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
II Klinika Pediatrii, Endokrynologii i Diabetologii Dziecięcej, Ul. Lwowska 60, 35-301, Rzeszow
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Klinika Pediatrii, Oddział Endokrynologii Dziecięcej, Ul. 3 Maja 13/15, 41-800, Zabrze
Unidade Local De Saude De Santo Antonio E.P.E.
NA, Largo Da Maternidade De Julio Dinis 45, 4050-651, Porto
Unidade Local De Saude De Gaia/Espinho E.P.E.
NA, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital CUF Porto S.A.
NA, Estrada Da Circunvalacao N 14341, 4100-180, Porto
Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
Pediatrie II, Bld. C-tin Brancoveanu nr. 20, Bucharest, Bucharest
Kilostop Junior S.R.L.
NA, Bl D1 Tronson 8 Et 6 Sector 1, Calea Victoriei No 155, Bucharest
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Pediatrie II BEGA, Celebi Evila 1-3, 300226, Timisoara
Narodny Endokrinologicky A Diabetologicky Ustav
Detske oddelenie, Kollarova 282/3, 034 91, Lubochna
Narodny Ustav Detskych Chorob
Endokrinologicka ambulancia detskej kliniky LFUK, Limbova 1, 833 40, Bratislava
Detska Fakultna Nemocnica Kosice
Ambulancia pediatrickej endokrinologie a diabetologie a poruch latkovej premeny a vyzivy, Trieda Snp 1, Zapad, Kosice
University Hospital Virgen Del Rocio S.L.
NA, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Sant Joan De Deu Barcelona
NA, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
NA, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 278 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_nn9838-4968-protocol-2023-509176-42-english_for-publication | 4.0 |
| Protocol (for publication) | d4_at_nn9838-4968-diabetes-diary-de-german-_for-publication | 1.0 |
| Protocol (for publication) | d4_at_nn9838-4968-dosing-diary-de-german-_for-publication | 1.0 |
| Protocol (for publication) | d4_at_nn9838-4968-low-blood-sugar-de-german-_for-publication | 1.0 |
| Protocol (for publication) | d4_at_nn9838-4968-pgi-c-de-german-_for-publication | 1.0 |
| Protocol (for publication) | d4_at_nn9838-4968-pgi-s-de-german-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-diabetes-diary-french-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-diabetes-diary-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-dosing-diary-french-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-dosing-diary-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-low-blood-sugar-diary-french-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-low-blood-sugar-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-pgi-c-french-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-pgi-c-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-pgi-s--french-_for-publication | 1.0 |
| Protocol (for publication) | d4_be_nn9838-4968-pgi-s-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_bg_nn9838-4968-diabetes-diary-bg-bulgarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_bg_nn9838-4968-dosing-diary-bg-bulgarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_bg_nn9838-4968-low-blood-sugar-bg-bulgarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_bg_nn9838-4968-pgi-c-bg-bulgarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_bg_nn9838-4968-pgi-s-bg-bulgarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_es_nn9838-4968-diabetes-diary-es-spanish-_for-publication | 1.0 |
| Protocol (for publication) | d4_es_nn9838-4968-dosing-diary-es-spanish-_for-publication | 1.0 |
| Protocol (for publication) | d4_es_nn9838-4968-low-blood-sugar-episode-es-spanish-_for-publication | 1.0 |
| Protocol (for publication) | d4_es_nn9838-4968-pgi-c-es-spanish-_for-publication | 1.0 |
| Protocol (for publication) | d4_es_nn9838-4968-pgi-s-es-spanish-_for-publication | 1.0 |
| Protocol (for publication) | d4_hr_nn9838-4968-diabetes-diary-hr-croatian-_for-publication | 1.0 |
| Protocol (for publication) | d4_hr_nn9838-4968-dosing-diary-hr-croatian-_for-publication | 1.0 |
| Protocol (for publication) | d4_hr_nn9838-4968-low-blood-sugar-hr-croatian-_for-publication | 1.0 |
| Protocol (for publication) | d4_hr_nn9838-4968-pgi-c-hr-croatian-_for-publication | 1.0 |
| Protocol (for publication) | d4_hr_nn9838-4968-pgi-s-hr-croatian-_for-publication | 1.0 |
| Protocol (for publication) | d4_hu_nn9838-4968-diabetes-diary-hu-hungarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_hu_nn9838-4968-dosing-diary-hu-hungarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_hu_nn9838-4968-low-blood-sugar-hu-hungarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_hu_nn9838-4968-pgi-c-hu-hungarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_hu_nn9838-4968-pgi-s-hu-hungarian-_for-publication | 1.0 |
| Protocol (for publication) | d4_it_nn9838-4968-diabetes-diary-it-italian-_for-publication | 1.0 |
| Protocol (for publication) | d4_it_nn9838-4968-dosing-diary-it-italian-_for-publication | 1.0 |
| Protocol (for publication) | d4_it_nn9838-4968-low-blood-sugar-it-italian-_for-publication | 1.0 |
| Protocol (for publication) | d4_it_nn9838-4968-pgi-c-it-italian-_for-publication | 1.0 |
| Protocol (for publication) | d4_it_nn9838-4968-pgi-s-it-italian-_for-publication | 1.0 |
| Protocol (for publication) | d4_nl_nn9838-4968-diabetes-diary-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_nl_nn9838-4968-dosing-diary-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_nl_nn9838-4968-low-blood-sugar-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_nl_nn9838-4968-pgi-c-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_nl_nn9838-4968-pgi-s-nl-dutch-_for-publication | 1.0 |
| Protocol (for publication) | d4_nn9838-4968-master-diabetes-diary-english_for-publication | 3.0 |
| Protocol (for publication) | d4_nn9838-4968-master-dosing-diary-english_for-publication | 1.0 |
| Protocol (for publication) | d4_nn9838-4968-master-low-blood-sugar-english_for-publication | 4.0 |
| Protocol (for publication) | d4_nn9838-4968-patient-facing-material-with-copyright-english_for-publication | 1.0 |
| Protocol (for publication) | d4_nn9838-4968-pgi-c-and-pgi-s-master-en-english_for-publication | 1.0 |
| Protocol (for publication) | d4_pl_nn9838-4968-diabetes-diary-pl-polish-_for-publication | 1.0 |
| Protocol (for publication) | d4_pl_nn9838-4968-dosing-diary-pl-polish-_for-publication | 1.0 |
| Protocol (for publication) | d4_pl_nn9838-4968-low-blood-sugar-pl-polish-_for-publication | 1.0 |
| Protocol (for publication) | d4_pl_nn9838-4968-pgi-c-pl-polish-_for-publication | 1.0 |
| Protocol (for publication) | d4_pl_nn9838-4968-pgi-s-pl-polish-_for-publication | 1.0 |
| Protocol (for publication) | d4_pt_nn9838-4968-diabetes-diary-pt-portuguese-_for-publication | 1.0 |
| Protocol (for publication) | d4_pt_nn9838-4968-dosing-diary-pt-portuguese-_for-publication | 1.0 |
| Protocol (for publication) | d4_pt_nn9838-4968-low-blood-sugar-pt-portuguese-_for-publication | 1.0 |
| Protocol (for publication) | d4_pt_nn9838-4968-pgi-c-pt-portuguese-_for-publication | 1.0 |
| Protocol (for publication) | d4_pt_nn9838-4968-pgi-s-pt-portuguese-_for-publication | 1.0 |
| Protocol (for publication) | d4_ro_nn9838-4968-diabetes-diary-ro-romanian-_for-publication | 1.0 |
| Protocol (for publication) | d4_ro_nn9838-4968-dosing-diary-ro-romanian-_for-publication | 1.0 |
| Protocol (for publication) | d4_ro_nn9838-4968-low-blood-sugar-ro-romanian-_for-publication | 1.0 |
| Protocol (for publication) | d4_ro_nn9838-4968-pgi-c-ro-romanian-_for-publication | 1.0 |
| Protocol (for publication) | d4_ro_nn9838-4968-pgi-s-ro-romanian-_for-publication | 1.0 |
| Protocol (for publication) | d4_se_nn9838-4968-diabetes-diary-sv-swedish-_for-publication | 1.0 |
| Protocol (for publication) | d4_se_nn9838-4968-dosing-diary-sv-swedish-_for-publication | 1.0 |
| Protocol (for publication) | d4_se_nn9838-4968-low-blood-sugar-se-swedish-_for-publication | 1.0 |
| Protocol (for publication) | d4_se_nn9838-4968-pgi-c-se-swedish-_for-publication | 1.0 |
| Protocol (for publication) | d4_se_nn9838-4968-pgi-s-se-swedish-_for-publication | 1.0 |
| Protocol (for publication) | d4_sk_nn9838-4968-diabetes-diary-sk-slovakian-_for-publication | 1.0 |
| Protocol (for publication) | d4_sk_nn9838-4968-dosing-diary-sk-slovakian-_for-publication | 1.0 |
| Protocol (for publication) | d4_sk_nn9838-4968-low-blood-sugar-sk-slovakian-_for-publication | 1.0 |
| Protocol (for publication) | d4_sk_nn9838-4968-pgi-c-sk-slovakian-_for-publication | 1.0 |
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| Subject information and informed consent form (for publication) | l1_it-nn9838-4968-piic-legal-age-main-_for-publication | 2.0 |
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| Subject information and informed consent form (for publication) | l1_nl-nn9838-4968-piic-future-research-legal-age-_for-publication | 3.0 |
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| Subject information and informed consent form (for publication) | l1_ro-nn9838-4968-piic-legal-age-future-research_for-publication | 1.0 |
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| Synopsis of the protocol (for publication) | d1_at_nn9838-4968-protocol-synopsis-for-experts-2023-509176-42-german-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_be_nn9838-4968-protocol-synopsis-2023-509176-42-dutch-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_be_nn9838-4968-protocol-synopsis-2023-509176-42-french-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_be_nn9838-4968-protocol-synopsis-2023-509176-42-german-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_bg_nn9838-4968-protocol-synopsis-2023-509176-42-bulgarian-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_es_nn9838-4968-protocol-synopsis-2023-509176-42-spanish-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_hr_nn9838-4968-protocol-synopsis-2023-509176-42-croatian-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_hu_nn9838-4968-protocol-synopsis-2023-509176-42-hungarian-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_it_nn9838-4968-protocol-synopsis-2023-509176-42-italian-_for-publication | 1.0 |
| Synopsis of the protocol (for publication) | d1_nl_nn9838-4968-protocol-synopsis-2023-509176-42-dutch-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_nn9838-4968-protocol-synopsis-2023-509176-42-english_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_nn9838-4968-protocol-synopsis-for-experts-2023-509176-42-english_for-publication | 1.0 |
| Synopsis of the protocol (for publication) | d1_pl_nn9838-4968-protocol-synopsis-2023-509176-42-polish-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_pt_nn9838-4968-protocol-synopsis-2023-509176-42-portuguese-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_ro_nn9838-4968-protocol-synopsis-2023-509176-42-romanian-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_se_nn9838-4968-protocol-synopsis-2023-509176-42-swedish-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_sk_nn9838-4968-protocol-synopsis-2023-509176-42-slovakian-_for-publication | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-09 | Denmark | Acceptable with conditions 2026-04-27
|
2026-04-28 |