Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
2,620
Countries
8
Sites
99
Obesity
To demonstrate that Orforglipron is non-inferior to insulin glargine (with a non-inferiority margin of 1.8) in occurrence of MACE-4 events
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 2 Aug 2023 → 17 Mar 2026
- Decision date (initial)
- 2023-08-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502833-25-00
- WHO UTN
- U1111-1285-6821
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety
To demonstrate that Orforglipron is non-inferior to insulin glargine (with a non-inferiority margin of 1.8) in occurrence of MACE-4 events
Conditions and MedDRA coding
Obesity
Regulatory references
- Scientific advice from competent authorities
- Lilly Corporate Center, Lilly Corporate Center
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- have Type 2 Diabetes
- Be taking a consistent dose of 1 to 3 diabetes drugs by mouth for the last 3 months
- Have heart disease
- Have high blood sugar as measured by hemoglobin A1C (HbA1c at least 7.0%)
Exclusion criteria 4
- Have type 1 diabetes
- Have history of inflamed liver (hepatitis)
- Have used any weight loss drugs, including herbal or nutritional supplements, within the last 3 month
- Have history of pancreatitis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) death]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD10193651 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193676 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193655 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193663 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193667 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193674 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
ABASAGLAR 100 units/mL KwikPen solution for injection in a pre-filled pen
PRD1664537 · Product
- Active substance
- Insulin Glargine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0 U unit(s)
- Max total dose
- 0 U unit(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10AE04 — INSULIN GLARGINE
- Marketing authorisation
- EU/1/14/944/008
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 10
SUB33463 · Substance
- Active substance
- Canagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 92400 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB31650 · Substance
- Active substance
- Dapagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3080 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB33463 · Substance
- Active substance
- Canagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 92400 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
A10BB · Product
- Active substance
- Sulfonamides, Urea Derivatives
- Pharmaceutical form
- -
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 6160 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BB — SULFONAMIDES, UREA DERIVATIVES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB31650 · Substance
- Active substance
- Dapagliflozin
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3080 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB35915 · Substance
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7700 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB182716 · Substance
- Active substance
- Ertugliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 4620 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB35915 · Substance
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7700 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP135808 · ATC
- Active substance
- Metformin
- Substance synonyms
- DIMETHYLDIGUANIDE
- Pharmaceutical form
- -
- Route of administration
- ORAL USE
- Max daily dose
- 2000 mg milligram(s)
- Max total dose
- 616000 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BA02 — METFORMIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB182716 · Substance
- Active substance
- Ertugliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 4620 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Cleveland Clinic Coordinating Center for Clinical Research (C5R) ORL-000000882
|
Cleveland, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| WCG Clinical Inc. ORG-100040730
|
Plymouth Meeting, United States | Code 10 |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
Locations
8 EU/EEA countries · 99 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 75 | 9 |
| Czechia | Ended | 215 | 19 |
| Germany | Ended | 114 | 14 |
| Greece | Ended | 66 | 6 |
| Italy | Ended | 114 | 9 |
| Romania | Ended | 183 | 19 |
| Slovakia | Ended | 170 | 12 |
| Spain | Ended | 103 | 11 |
| Rest of world
India, Turkey, Mexico, Brazil, Argentina, United States, Korea, Republic of
|
— | 1,580 | — |
Investigational sites
Konvent Der Barmherzigen Brueder
Internal Medicine, Seilerstaette 2, 4020, Linz
Private Practice - Dr. Evelyn Fließer-Görzer
Private Practice - Dr. Evelyn Fließer-Görzer, Kastaniensiedlung 1, 8511, Sankt Stefan ob Stainz
A.O. Krankenhaus St. Josef Braunau GmbH
Internal Medicine I, Ringstrasse 60, 5280, Braunau Am Inn
Klinik Hietzing
Karl Landsteiner Institute for Metabolic Disease and Nephrology, Wolkersbergenstrasse 1, Hietzing, Vienna
Zentrum Fur Klinische Studien Dr. Hanusch GmbH
Zentrum Fur Klinische Studien Dr. Hanusch GmbH, Gumpendorfer Strasse 95/9, Mariahilf, Vienna
Vivit Institute
VIVIT - Vorarlberg Institute for Vascular Investigation and Treatment, Carinagasse 47, 6800, Feldkirch
Klinik Landstrabe
1st Medical Department, Juchgasse 25, Landstrasse, Vienna
Medical University Of Vienna
Department of Medicine III, Division of Endocrinology and Metabolism, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University Of Graz
Department of Internal Medicine, Division of Endocrinology and Diabetology, Neue Stiftingtalstrasse 6, 8010, Graz
Praglandia s.r.o.
NA, Nadrazni 3368/30a, Smichov, Prague
Fledip s.r.o.
NA, Tetinska 331/2, 150 00, Prague 5
MUDr. Michala Pelikanova s.r.o.
NA, Hudeckova 1043/10, Podoli, Prague 4
Milan Kvapil s.r.o.
NA, Lucni 1611, 263 01, Dobris
Dialine s.r.o.
NA, Tylova 502/39, Jizni Predmesti, Plzen 3
DIACENTRUM Brandys n.L. s.r.o.
Diabetology, Jiriho Wolkera 603/1, 250 01, Brandys Nad Labem
Nefromed s.r.o.
NA, Africka 687/36, Vokovice, Prague 6
MEDICON a.s.
N/A, Antala Staska 1670/80, Krc, Prague 4
Edumed s.r.o.
NA, Mlynska 189, 547 01, Nachod
TreDia s.r.o.
NA, Doninska 1858, Ujezd Nad Lesy, Prague 21
Edumed s.r.o.
NA, Smetanova 91, 550 01, Nove Mesto
Edumed s.r.o.
NA, Dr. Ed. Benese 191, Prazske Predmesti, Jaromer
MUDr. Miroslav Koliba s.r.o.
N/A, Bieblova 410/2, Moravska Ostrava, Ostrava
Diahelp s.r.o.
Internal and diabetology, Pod Brizkami 897, Zelene Predmesti, Pardubice V
Nemocnice Cesky Krumlov a.s.
Internal, Nemocnicni 429, 381 01, Horni Brana
Preventamed s.r.o.
NA, Domovina 774/2, 779 00, Olomouc
MUDr. Tomas Edelsberger
Diabetology, Náměstí Minoritů 86/7, 79401, Krnov
Aidin VK s.r.o.
NA, Na Naspech 78, 753 01, Hranice I-Mesto
EFERTUS healthcare s.r.o.
N/A, Vinicni 4049/235, Zidenice, Brno
Red Institut Fur Medizinische Forschung Und Weiterbildung
NA, Markt 15, 23758, Oldenburg In Holstein
Diabetologische Schwerpunktpraxis Marck Linn Pickel
N/A, Neue Mitte 10, Watzenborn-Steinberg, Pohlheim
Diabetespraxis Dr. Braun
N/A, Breite Str. 41, Berlin, Berlin
Bag Diabeteszentrum Dr. Tews & Partner
NA, 4 Obergeschoss, Herzbachweg 14e, Gelnhausen
Gemeinschaftspraxis für Diabetologie
N/A, Clemdastrasse 1, 99817, Eisenach
Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte
N/A, Schlüsselbergstrasse 6, Bayern, Mühldorf
Praxis am Markt – Dr. Bernd Becker
N/A, Weidkamp 1, Nordrhein-Westfalen, Essen
Gesundheitsverbund Landkreis Konstanz gGmbH
Medizinische Klinik I Kardiologie, Virchowstrasse 10, 78224, Singen (Hohentwiel)
Centrum für Diabetologie und Allgemeinmedizin
N/A, Neue Mitte 10, Haus 4, Pohlheim
MVZ im Altstadt-Carree Fulda GmbH
N/A, Dalbergstrasse 22, Innenstadt, Fulda
Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
N/A, Gerhard-Ellrodt-Str. 19, 04249, Leipzig
Medic-Center Nürnberg - Schöll & Kollegen
NA, Gibitzenhofstraße 62, Nürnberg, Nürnberg
Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
NA, August-Mohl-Strasse 37, Hof, Hof
Smo Md GmbH
NA, Bierer Weg 9, Leipziger Str., Magdeburg
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Department, Rimini Street 1, 124 62, Athens
General Hospital Of Lamia
Department of Internal Medicine, Papasiopoulou End, 351 00, Lamia
Athens Medical Center S.A.
Diabetes Department, Areos 36, 175 62, Paleo Faliro
General Hospital Of Athens G Gennimatas
Endocrinology Department, Messogion Avenue 154, 115 27, Athens
Laiko General Hospital Of Athens
Diabetes Center, 1st Propaedeutic Internal Medicine Department, Agiou Thoma (goudi) 17, 115 27, Athens
General Hospital Of Thessloniki G Gennimatas
Internal Medicine Clinic, Ethnikis Aminis 41, 546 35, Thessaloniki
Hospital Santa Maria Della Misericordia
Struttura Complessa di endocrinologia e malattie metaboliche, Piazzale Giorgio Menghini 1, 06129, Perugia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOSD Diabetologia, Largo Francesco Vito 1, 00168, Rome
Magna Graecia University Of Catanzaro
Metabolic Diseases, Viale Europa Localita Germaneto, 88100, Catanzaro
Ospedale San Raffaele S.r.l.
Unità Cardio-Metabolica e Trials Clinici, Via Olgettina 60, 20132, Milan
Azienda Sanitaria Universitaria Giuliano Isontina
Centro diabetologico DST- ASUGI, Via Costantino Costantinides 2, 34128, Trieste
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento di Medicina Clinica e Chirurgia, Via Sergio Pansini 5, 80131, Naples
Universita' Degli Studi G. D'annunzio Di Chieti Pescara
Clinical research Center - CAST, Via Dei Vestini 31, 66100, Chieti
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU ENDOCRINOLOGIA, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ospedaliera Universitaria Senese
UOC Diabetologia, Viale Mario Bracci 2, 53100, Siena
Consultmed S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli metabolice, Block 550, Soseaua Pacurari 70, Jassi
Easydiet S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, Strada Mr. Sontu Gheorghe Nr 3, 011447, Bucharest
Diabdana S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, Calea Republicii Nr 77, 410147, Oradea
Nutrilife S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest
Societatea Civila Medicala Dr. Paveliu
Specialitatea–Diabet zaharat, nutritie si boli metabolice, Strada Dr. Iatropol Panait 24, 050538, Bucharest
Mariodiab Clinic S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, Block 75 Scara A, Bulevardul 15 Noiembrie Nr 75, Brasov
Minimed S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, Strada Pacii Nr.7, 600274, Bacau
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli metabolice, Strada Crisului Nr. 1, 500283, Brasov
Nicodiab S.R.L.
Retrieving data. Wait a few seconds and try to cut or copy again., Strada Titeica Gheorghe 202-204, 020305, Bucharest
Diabmed Dr. Popescu Alexandrina S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, Strada Sighet Nr 4, 100163, Ploiesti
Diamed Obesity S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli metabolice, Gheorghe Doja Nr 73, 800291, Galati
Hightech Medical Services S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli metabolice, Sector 1, Alexandra Ioan Cuza Blvd 76, Bucharest
Grandmed S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli metabolice, Calea Republicii Nr 32, Ap. 1, Oradea
Mediab S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, Apartament I-II, Strada Marinescu Gheorghe Nr 8a, Targu Mures
Clinica Korall S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, P-Ta Eroii Revolutiei, Corp A Apartament M-2 Nr 22, Satu Mare
Milena Sante S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, Strada Balcescu Nicolae Nr 31, 800001, Galati
Sc Cmi Dr. Pletea Noemi S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli, Strada Stadionului Nr 3a Parter, 600154, Bacau
Cabinet Medical Dr Geru S.R.L.
Specialitatea–Diabet zaharat, nutritie si boli metabolice, Aleea Lirei Nr 1, Ap. 2, Timisoara
Cardiomed S.R.L.
Diabetes, Nutrition, and metabolic diseases, Aleea Neculai Tudor C1, 700732, Jassi
Tatratrial s.r.o.
NA, Namestie 1. Maja 11, 048 01, Roznava
Areteus s.r.o.
NA, M. R. Stefanika 25a/3782, 075 01, Trebisov
Diabint s.r.o.
NA, Sidonie Sakalovej 161/16, Velka Bytca, Bytca
Narodny Endokrinologicky A Diabetologicky Ustav
NA, Kollarova 282/3, 034 91, Lubochna
Metabol KLINIK s.r.o.
NA, Cukrova 3, 811 08, Stare Mesto
In Dia s.r.o.
NA, Mierova 1, 984 01, Lucenec
MediVet s.r.o.
NA, Jana Holleho 1672/24, 901 01, Malacky
Diacrin s.r.o.
NA, Kosicka 43/d, 821 08, Ruzinov
Medi-Dia s.r.o.
NA, Namestie Slobody 65, 083 01, Sabinov
Human-Care s.r.o.
NA, Rastislavova 45, 040 01, Kosice 1
JAL s.r.o.
NA, Trhova 4, 917 01, Trnava
DIA MED CENTRUM s.r.o.
NA, Tajovskeho 8568/3, 010 01, Zilina
Hospital Universitario Quironsalud Madrid
Endocrinology and nutrition, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De La Ribera
Endocrinology, Carretera Corbera 1, 46600, Alzira
Hospital Nisa Sevilla Aljarafe
Endocrinology, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
NA, Calle Alejo Fernandez 9, 41003, Sevilla
Hospital Universitario Reina Sofia
Internal Medicine, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital General De Segovia
Endocrinology and nutrition, Calle De Luis Erik Claveria, 47002, Segovia
Complexo Hospitalario Universitario A Coruna
Endocrinology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Ruber Juan Bravo
Endocrinology and nutrition, Calle De Juan Bravo 49, 28006, Madrid
University Hospital Virgen Del Rocio S.L.
Endocrinology and nutrition, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Marques De Valdecilla
Endocrinology, Diabetes & Nutrition, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Central De Asturias
Endocrine & Nutrition, Avenida De Roma S/n, 33011, Oviedo
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 | 2023-11-08 | 2026-03-16 | 2023-11-14 | 2024-08-08 | |
| Czechia | 2023-08-03 | 2026-03-16 | 2023-08-18 | 2024-08-08 | |
| Germany | 2023-08-02 | 2026-03-16 | 2023-08-07 | 2024-08-08 | |
| Greece | 2023-08-31 | 2026-03-16 | 2023-09-01 | 2024-08-08 | |
| Italy | 2023-09-06 | 2026-03-16 | 2023-09-22 | 2024-08-08 | |
| Romania | 2023-08-16 | 2026-03-16 | 2023-08-18 | 2024-08-08 | |
| Slovakia | 2023-08-03 | 2026-03-16 | 2023-08-18 | 2024-08-08 | |
| Spain | 2023-08-03 | 2026-03-16 | 2023-08-22 | 2024-08-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 177 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Blanket Statement - Document not published | 2.0 |
| Protocol (for publication) | D1_ Protocol 2022-502833-25-00_Redacted | e |
| Protocol (for publication) | D1_Protocol_GR_2022-502833-25-00_Redacted | e |
| Protocol (for publication) | D4_Patient Documents Copyright Statement | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Insulin_Titration_Diary_IT | 1.0 |
| Protocol (for publication) | D4_Patient Information Card | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements IT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_CWM_Master_WS_Script_Master | 3 |
| Recruitment arrangements (for publication) | K2_CWM_Program_Website_Copy_Master | 3 |
| Recruitment arrangements (for publication) | K2_CWM_Program_Website_Policies_Master | 1 |
| Recruitment arrangements (for publication) | K2_CWM_Screener_Edition 2_Master_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_CWM_Search_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_FLYER_MASTER | 2.1 |
| Recruitment arrangements (for publication) | K2_FLYER-DG_MASTER | 2.1 |
| Recruitment arrangements (for publication) | K2_General Description of Web Application_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Indication_Digital_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_List of paticipating sites_SK_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_List of paticipating sites_SK_Redacted_SM-9 | 2.0 |
| Recruitment arrangements (for publication) | K2_List of paticipating sites_SK_SM-13_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_List of paticipating sites_SK_tracked_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient_Messaging_Master_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_POSTER_MASTER | 2.1 |
| Recruitment arrangements (for publication) | K2_Print media_Invoice offer_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment and Informed consent procedure_SK | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material CWM_Program_Website_Policies_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material List of planned sites_CZ_Clean_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material List of planned sites_CZ_TC_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Master_WS_Script_GR | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Master_WS_Script_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Copy_GR | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Copy_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Policies_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Screener_Edition 2_Master_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Screener_GR_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Search_Ads_Master_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital_Ads_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Fliesser-Goerzer_PPFG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FLYER DG_GR | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer DG_Master_IT | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FLYER_GR | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FLYER_MASTER_CZ | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_Master_IT | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZGS_Website_Copy_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Hanusch_PPH | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Indication_Digital_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Indication_Digital_Ads_Master_IT | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_LETTER-PARTICIPANT-WELCOME_MASTER_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of planned sites_CZ_Redacted | 5.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master_WS_Script_Master_IT | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient_Messaging_GR_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient_Messaging_Master_IT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient_Messaging_Master_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_POSTER_GR | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_POSTER_MASTER_CZ | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print media_Advertisement | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Program_Website_Copy_Master_IT | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Program_Website_Policies_Master_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Screener_Edition 2_Master_IT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Search Ads GZGS Keywords_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Search Ads Osteoarthritis Keywords_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Search Ads Overall program keywords_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Search Ads Sleep Apnea Keywords_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Search_Ads_Master_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Sourij_MUG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_STUDY-GUIDE_MASTER_CZ_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_STUDY-GUIDE_MASTER_IT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_TRIAL BROCHURE DG_MASTER_IT_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL_BROCHURE_MASTER_IT_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL-BROCHURE DG_GR_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL-BROCHURE_GR_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL-BROCHURE_MASTER_CZ_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_VISIT-CARD_MASTER_CZ | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_Copy_GR | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_Copy_Master_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_Social media | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_Social media_2_Redacted | 5.2 |
| Recruitment arrangements (for publication) | K2_STUDY GUIDE_MASTER_SK_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_STUDY-GUIDE_MASTER_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_STUDY-GUIDE-DG_MASTER_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_TRIAL-BROCHURE_MASTER_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_TRIAL-BROCHURE-DG_MASTER_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_VISIT CARD_MASTER_SK | 2.0 |
| Recruitment arrangements (for publication) | K2_Website_Copy_Master | 2 |
| Recruitment arrangements (for publication) | K3_List of Planned Sites and Subjects_IT | N/A |
| Recruitment arrangements (for publication) | K3_List of Planned Sites and Subjects_IT_TC | N/A |
| Subject information and informed consent form (for publication) | D4_EC_packet_w_Data_Laws_as_applied_to_GP_Czech | 1 |
| Subject information and informed consent form (for publication) | D4_Greenphire ClinCard Msg Templates - ROW_Certificate_Czech | 1 |
| Subject information and informed consent form (for publication) | D4_Greenphire ClinCard Msg Templates - ROW_Czech | 1 |
| Subject information and informed consent form (for publication) | D4_Greenphire EU Generic ClinCard_Template | 1 |
| Subject information and informed consent form (for publication) | D4_Greenphire_ClinCard_Card_Carrier_EU_Certificate_Czech | 1 |
| Subject information and informed consent form (for publication) | D4_Greenphire_ClinCard_Card_Carrier_EU_Czech | 1 |
| Subject information and informed consent form (for publication) | D4_Greenphire_ClinCard_Cardholder_FAQ_EU_Certificate_Czech | 1 |
| Subject information and informed consent form (for publication) | D4_Greenphire_ClinCard_Cardholder_FAQ_EU_Czech | 1 |
| Subject information and informed consent form (for publication) | D4_Greenphire_Fee_Schedule_Certificate_Czech | 1 |
| Subject information and informed consent form (for publication) | D4_Greenphire_Fee_Schedule_Czech | 1 |
| Subject information and informed consent form (for publication) | D4_Patient Information Card | 2.0 |
| Subject information and informed consent form (for publication) | D4_Patient Information Card_CZ | 5 |
| Subject information and informed consent form (for publication) | GZGS_Appreciation Items_Master_EN | 1 |
| Subject information and informed consent form (for publication) | K2_Recruitment Material_FLYER_MASTER_IT | 2.0 |
| Subject information and informed consent form (for publication) | K2_Recruitment Material_STUDY-GUIDE_MASTER_IT | 2.0 |
| Subject information and informed consent form (for publication) | K2_Recruitment Material_TRIAL_BROCHURE_MASTER_IT | 2.0 |
| Subject information and informed consent form (for publication) | K2_Recruitment Material_VISIT-CARD_MASTER_IT | 2.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main Adults_Italy_tc_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Participant_Italy_clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Participant_Italy_tc_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner_Italy_clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner_Italy_tc_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Data Privacy Addendum_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Data Privacy Addendum_SK | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner_GR | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Austria_clean_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_Main ICF_CZ_Czech_track changes_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Main ICF_CZ_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Highlighted_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_IT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_SK_clean_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_SK_tracked_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_TC_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_AT_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Reimbursement ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Reimbursement ICF_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_Travel Cost and Booking Program ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Travel Cost and Booking Program ICF_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2 GP Letter_Italy_tc_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Subject Thank You Card _IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Appreciation Items | 1 |
| Subject information and informed consent form (for publication) | L2_Appreciation Items_Master | 1 |
| Subject information and informed consent form (for publication) | L2_Clinical Trial Ancillary Supply List_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ConneX_Austria Travel Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_ConneX_Austria Travel Ref Guide for Subjects | 1 |
| Subject information and informed consent form (for publication) | L2_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP | 1 |
| Subject information and informed consent form (for publication) | L2_Contact card_Participant_AC | 1 |
| Subject information and informed consent form (for publication) | L2_Contact card_Participant_SD | 1 |
| Subject information and informed consent form (for publication) | L2_Country Patient Information Card IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_GP letter_IT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Letter_Participant_Welcome | 1 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient information card | 5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material STUDY_GUIDE_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material STUDY-GUIDE DG_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Items list | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_THANK_YOU_PARTICIPATION_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_THANK_YOU_SCREENING_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VISIT_CARD_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Reimbursement Form_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Reimbursement Form_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Visit-Card_Master | 2 |
| Subject information and informed consent form (for publication) | L3_Appreciation Items | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Clodi_BBL | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_Fliesser-Goerzer_PPFG | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_Hanusch_PPH | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_Kautzky-Willer_MUW | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_Ludvik__KL | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_master | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_Sourij_MUG | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_Stulnig_KH | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_Vonbank_VIVIT | 1 |
| Subject information and informed consent form (for publication) | Travel reimbursement ICF_CZ_Redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Abasaglar | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502833-25-00_GR_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_2022-502833-25-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2022-502833-25-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2022-502833-25-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GER_2022-502833-25-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2022-502833-25-00 Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2022-502833-25-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SK_2022-502833-25-00_Redacted | e |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-04 | Slovakia | Acceptable 2023-07-31
|
2023-08-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-17 | Acceptable | 2023-11-06 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-09-19 | Acceptable | 2023-10-25 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-09-19 | Acceptable | 2023-12-01 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-09-27 | Acceptable | 2023-11-27 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-09-27 | Acceptable | 2023-11-07 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-10-03 | Acceptable | 2023-11-14 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-10-12 | Acceptable | 2023-11-24 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-02-27 | Slovakia | Acceptable 2024-04-29
|
2024-04-30 |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-06-21 | Acceptable | 2024-08-01 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-10-22 | Acceptable | 2025-01-13 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-11-06 | 2025-01-08 | ||
| 13 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-12-20 | Slovakia | Acceptable | 2025-02-18 |
| 14 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-05-07 | Slovakia | Acceptable | 2025-06-27 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-10 | Slovakia | Acceptable | 2025-07-10 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-14 | Acceptable | 2025-07-14 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-15 | Slovakia | Acceptable | 2025-07-15 |
| 18 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-08-21 | Slovakia | Acceptable 2025-10-21
|
2025-10-21 |
| 19 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-12-05 | Acceptable | 2026-02-02 |