Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
13,299
Countries
14
Sites
227
Type 2 Diabetes Mellitus
To assess efficacy of maximally tolerated tirzepatide dose up to 15 mg QW compared to QW dulaglutide 1.5 mg on time to first occurrence of the composite endpoint of death from CV causes, MI, or stroke (MACE-3) when both are added to standard of care in patients with T2DM and high CV risk. Primary analysis will be an as…
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 19 Jun 2020 → 13 Jun 2025
- Decision date (initial)
- 2023-11-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507846-96-00
- EudraCT number
- 2019-002735-28
- WHO UTN
- U1111-1297-7639
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacogenetic, Pharmacoeconomic
To assess efficacy of maximally tolerated tirzepatide dose up to 15 mg QW compared to QW dulaglutide 1.5 mg on time to first occurrence of the composite endpoint of death from CV causes, MI, or stroke (MACE-3) when both are added to standard of care in patients with T2DM and high CV risk. Primary analysis will be an assessment of NI of tirzepatide to dulaglutide for MACE-3. After establishing NI, superiority of tirzepatide compared to dulaglutide for MACE-3 will be evaluated.
Conditions and MedDRA coding
Type 2 Diabetes Mellitus
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Have a diagnosis of type 2 diabetes
- Have confirmed atherosclerotic cardiovascular disease
- HbA1c ≥7.0% to ≤10.5%
- Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)
Exclusion criteria 11
- Have had a major cardiovascular event within the last 60 days
- Have type 1 diabetes mellitus
- Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
- Are currently planning treatment for diabetic retinopathy and/or macular edema
- Currently planning a coronary, carotid, or peripheral artery revascularization
- Have a history of pancreatitis
- Have a history of ketoacidosis or hyperosmolar state/coma
- Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
- Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
- Time to First Occurrence of a component event of MACE-3
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD7107377 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 7.5 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107380 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 3.75 g gram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107376 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107375 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107379 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 12.5 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107378 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
SCP720269 · ATC
- Active substance
- Dulaglutide
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 1.5 mg milligram(s)
- Max total dose
- 390 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ05 — DULAGLUTIDE
- 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 13
| Organisation | City, country | Duties |
|---|---|---|
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Other |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Langland ORL-000002964
|
LONDON, United Kingdom | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 5 |
| Q2 Solutions BioSciences, LLC ORL-000002965
|
Indianapolis, United States | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Code 10 |
Locations
14 EU/EEA countries · 227 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 81 | 6 |
| Belgium | Ended | 131 | 14 |
| Czechia | Ended | 228 | 10 |
| France | Ended | 150 | 11 |
| Germany | Ended | 986 | 46 |
| Greece | Ended | 320 | 10 |
| Hungary | Ended | 375 | 17 |
| Italy | Ended | 217 | 20 |
| Netherlands | Ended | 129 | 18 |
| Poland | Ended | 449 | 19 |
| Romania | Ended | 565 | 20 |
| Slovakia | Ended | 163 | 10 |
| Spain | Ended | 409 | 20 |
| Sweden | Ended | 98 | 6 |
| Rest of world
United Kingdom, China, Turkey, Ukraine, Brazil, Taiwan, India, Japan, Argentina, Mexico, Israel, Korea, Republic of, Australia, Canada, United States, Russian Federation
|
— | 8,998 | — |
Investigational sites
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Klinische Abteilung für Endokrinologie und Stoffwechsel, Universitätsklinik für Innere Medizin III, Waehringer Guertel 18-20, Alsergrund, Vienna
Klinik Hietzing
Karl Landsteiner Institute for Metabolic Disease and Nephrology, Wolkersbergenstrasse 1, Hietzing, Vienna
Medical University Of Graz
Diabetes- und Stoffwechselambulanz, Auenbruggerplatz 14, 03 Bez Geidorf, Graz
Klinik Landstrabe
1st Medical Department, Juchgasse 25, Landstrasse, Vienna
Zentrum Fur Klinische Studien Dr. Hanusch GmbH
Zentrum für Klinische Studien Dr. Hanusch GmbH, Gumpendorfer Strasse 95/9, Mariahilf, Vienna
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Innere Medizin I, Muellner Hauptstrasse 48, 5020, Salzburg
Az St-Jan Brugge-Oostende A.V.
Endocrinology, Ruddershove 10, 8000, Brugge
Algemeen Ziekenhuis Groeninge
Endocrinology, President Kennedylaan 4, 8500, Kortrijk
Imelda
Endocrinology, Imeldalaan 9, 2820, Bonheiden
Algemeen Ziekenhuis Damiaan Oostende
Endocrinology, Gouwelozestraat 100, 8400, Ostend
CHU De Liege
Endocrinology-Diabetology, Bld Du Douzieme-De-Ligne 1, 4000, Liege
Antwerp University Hospital
Endocrinology-Diabetology, Drie Eikenstraat 655, 2650, Edegem
Algemeen Ziekenhuis Klina
Cardiology, Augustijnslei 100, 2930, Brasschaat
Vitaz
Endocrinology, Moerlandstraat 1, 9100, Sint-Niklaas
Het Ziekenhuisnetwerk Antwerpen
Endocrinology, Lange Bremstraat 70, 2170, Antwerp
UZ Brussel
Diabetology, Laarbeeklaan 101, 1090, Jette
Onze-Lieve-Vrouwziekenhuis
Endocrinology, Moorselbaan 164, 9300, Aalst
Katholieke Universiteit te Leuven
Endocrinology, Herestraat 49, 3000, Leuven
Algemeen Ziekenhuis Delta
Endocrinology, Deltalaan 1, 8800, Roeselare
Hopital Erasme
Endocrinology, Lennikse Baan 808, 1070, Anderlecht
Diabetologicka a obezitologicka ambulance Lekarsky dum Gecko
N/A, Ceske Vrbne 2403, 37011, Ceske Budejovice
ResTrial s.r.o.
N/A, Zhorelecka 514/2, Bohnice, Prague 8
Diabet2 s.r.o.
N/A, Revolucni 765/19, Stare Mesto, Prague 1
MUDr. Tomas Edelsberger
N/A, Náměstí Minoritů 86/7, 79401, Krnov
Vseobecna Fakultni Nemocnice V Praze
III Interni klinika endokrinologie a metabolismu, Karlovo Namesti 554/32, Nove Mesto, Prague 2
TreDia s.r.o.
N/A, Doninska 1858, Ujezd Nad Lesy, Prague 21
MUDr. Michala Pelikanova s.r.o.
N/A, Hudeckova 1043/10, Podoli, Prague 4
Milan Kvapil s.r.o.
N/A, Michnova 1622/4, Chodov, Prague
DIACENTRUM Brandys n.L. s.r.o.
N/A, Jiriho Wolkera 603/1, 250 01, Brandys Nad Labem
Interni a diabetologicka ordinace s.r.o.
NA, Nemcove 738, 547 01, Nachod
Groupe Sos Sante
Diabetology, 175 Rue Marechal Foch, 71200, Le Creusot
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Service de Diabétologie -endocrinologie et nutrition, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
Centre De Recherche Clinique Portes Du Sud
Diabetology, 2 Avenue Du 11 Novembre 1918, 69200, Venissieux
Assistance Publique Hopitaux De Paris
Diabétologie et endocrinologie, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Assistance Publique Hopitaux De Paris
Service de Diabétologie -endocrinologie et nutrition, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire De Bordeaux
Endocrinologie, diabétologie, Nutrition, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Toulouse
Diabetologie, maladies métaboliques et nutrition, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
CHRU De Nancy
Endocrinologie diabetologie, Vandoeuvre-Les-Nancy Cedex, 11 Rue Du Morvan, Vandoeuvre Les Nancy Cedex
Centre Hospitalier Universitaire De Dijon
Endocrinology-Diabetology, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Centre Hospitalier Sud Francilien
N/A, 40 Avenue Serge Dassault, 91100, Corbeil Essonnes
Centre Hospitalier Universitaire De Nantes
CIC EDN, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Praxis Dr. Veronika Wenzl-Bauer & Dr. Josef Wenzl
N/A, Bahnhofstr. 1a, 66780, Rehlingen-Siersburg
Gemeinschaftspraxis Dr. Täschner Dr. Bonigut
N/A, Gerhard-Ellrodt-Str. 19, 04249, Leipzig
Praxis Fuer Innere Medizin
N/A, Weinhold-Arkade 4, 04442, Zwenkau
Vinzenz Von Paul Kliniken gGmbH
Zentrum für Innere Medizin I, Boeheimstrasse 37, Sued, Stuttgart
Institut fuer Diabetesforschung Muenster GmbH
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
Diabetes-Zentrum-Wilhelmsburg GbR
N/A, Krieterstrasse 30, Wilhelmsburg, Hamburg
Cardiologicum Dresden & Pirna
N/A, Enderstr. 59, 01277, Dresden
Smo Md GmbH
N/A, Bierer Weg 9, Leipziger Str., Magdeburg
Schwerpunktpraxis für Diabetes, Gefäß- und Ernährungsmedizin
N/A, Poststr. 48-50, 14612, Falkensee
St. Josefskrankenhaus Heidelberg GmbH
N/A, Landhausstrasse 25, Weststadt, Heidelberg
Studienzentrum Christine Kosch
N/A, Königsteiner Str. 6B, 01796, Pirna
Diabetes- und Stoffwechselpraxis Bochum
N/A, In der Hönnebecke 80, 44869, Bochum
Praxis Am Markt
N/A, Weidkamp 1, 45355, Essen
Velocity Clinical Research Germany GmbH
N/A, Rosa-Luxemburg-Strasse 20, Zentrum-Ost, Leipzig
BAG Diabeteszentrum Dr. Tews & Partner
N/A, Herzbachweg 14E, Haus E, Gelnhausen
Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle
N/A, Beserlerstraße 2 A, 22607, Hamburg
CIMS Studienzentrum Bamberg GmbH
N/A, Buger Strasse 82, Berg, Bamberg
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
N/A, Galenstrasse 3, Spandau, Berlin
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Diabetologikum DDG Ludwigshafe
N/A, Ludwigsplatz 9, 67059, Ludwigshafen
Praxis Dres. Denger/Pfitzner
N/A, Zum Grühlingsstollen 3, 66299, Friedrichsthal
Medizinisches Versorgungszentrum Jung GbR
N/A, Ditzenbacher Strasse 33, 73326, Deggingen
Praxis Dr. Sarnighausen
N/A, Auf der Höhe 69, 21339, Lüneburg
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
N/A, Georgstrasse 11, Innenstadt, Bad Oeynhausen
Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
N/A, An der Pforte 5, 06679, Hohenmölsen
Diabetespraxis Dr Braun
N/A, Breite Strasse 41, 13187, Berlin
Diabetologische Schwerpunktpraxis
N/A, Clemdastr. 1, 99817, Eisenach
Diabetologische Schwerpunktpraxis Diabetologikum Speyer
N/A, Hilgardst. 30, 67346, Speyer
Praxis Sauter & Sauter & Dr. Vorbach
N/A, Herrenstr. 22-24, 88239, Wangen
Diabetologische Schwerpunktpraxis Harburg
N/A, Am Wall 1, 21073, Hamburg
Praxis Reinfeld Mitte
N/A, Paul-von-Schoenaich-Straße 29, 23858, Reinfeld
MVZ im Altstadt-Carree Fulda GmbH
N/A, Dalbergstrasse 22, Innenstadt, Fulda
Centrum Fuer Diabetologie Und Allgemeinmedizin
N/A, Haus 4, Neue Mitte 10, Pohlheim
Praxis Am Oberen Tor
N/A, Kronacher Strasse 1, 96215, Lichtenfels
Ambenet GmbH Das Ambulante Behandlungsnetz
N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Praxis für Prävention und Therapie
N/A, Brombeerweg 6, 78048, Villingen-Schwenningen
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
N/A, Kampstrasse 45, Mitte, Dortmund
Medizentrum Essen Borbeck
N/A, Huelsmannstrasse 6, Borbeck, Essen
Zentrum fuer klinische Studien Suedbrandenburg GmbH
N/A, Lange Strasse 13, 04910, Elsterwerda
Medizinisches Versorgungszentrum Riesa
N/A, Chemnitzer Str. 26, 01587, Riesa
Universitaetsklinikum Schleswig-Holstein
Institut für Endokrinologie, Ratzeburger Allee 160, 23538, Lübeck
CDG Studienambulanz Dr. Hartard
N/A, Helene-Mayer-Ring 14/1, 80809, München
Schwerpunktpraxis Diabetes
N/A, Hauptstr. 98, 66386, St. Ingbert-Oberwürzbach
ClinPhenomics CVC GmbH
N/A, Schaumainkai 101-103, Sachsenhausen, Frankfurt Am Main
Universitätsstudienzentrum für Stoffwechselerkrankungen
N/A, Fiedlerstr. 34, 01307, Dresden
General Hospital Of Athens G Gennimatas
Endocrinology Department, Messogion Avenue 154, 115 27, Athens
Ippokratio General Hospital Of Thessaloniki
Diabetes Center, 2nd Propaedeutic Internal Medicine Clinic, Konstadinoupoleos 49, 546 42, Thessaloniki
Thermi Clinic S.A.
1st Department of Internal Medicine, 14th Kms N Moudanion, 570 01, Thessaloniki
Athens Euroclinic S.A.
Diabetes Center, Athanassiadou 7-9, 115 21, Athens
University General Hospital Of Thessaloniki Ahepa
Endocrinology-Diabetology Department, 1st St Kiriakidis Str, 546 36, Thessaloniki
General Hospital Of Thessaloniki Papageorgiou
1st Department of Internal Medicine, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Athens Medical Center S.A.
Diabetes Department, Areos 36, 175 62, Paleo Faliro
Euromedica General Clinic Of Thessaloniki
Endocrinology Department, Kallas Marias 11, Gravias 2, Thessaloniki
General University Hospital Of Larissa
Endocrinοlogy Clinic and Metabolic Diseases, P. O. Box 1425, 411 10, Larissa
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Department, Rimini Street 1, 124 62, Athens
ClinDiab Kft.
N/A, Benyovszky Moric Utca 10/VIII, VIII Kerulet, Budapest VIII
Clinfan Kft.
Gasztroenterologia, Pollack Mihaly Utca 50, 7100, Szekszard
University Of Debrecen
Belgyogyaszat, Bartok Bela Ut 2-26, 4031, Debrecen
Szent Margit Rendelointezet Nonprofit Kft.
Diabetologia, Vorosvari Ut 88-96/III, III Kerulet, Budapest III
Pharma 4 Trial Kft.
N/A, Torok Ignac Utca 17, 3200, Gyongyos
Komaromi Selye Janos Korhaz
Diabetologia, Beothy Zsolt Utca 4, 2900, Komarom
Zala Varmegyei Szent Rafael Korhaz
Diabetologia D épület 2. emelet 225/226-os ajtó, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
II. Sz. Belgyógyászati Osztály, Seregelyesi Ut 3, 8000, Szekesfehervar
Kanizsai Dorottya Korhaz
Diabetes, Szekeres Jozsef Utca 2-8, 8800, Nagykanizsa
Central Hospital Of Northern Pest Military Hospital
Diabetologia, Robert Karoly Korut 44, 1134, Budapest XIII
University Of Szeged
Belgyogyaszati Klinika, Kalvaria Sugarut 57, 6725, Szeged
Markhot Ferenc Oktatokorhaz Es Rendelointezet
III. Belosztaly, Knezich Karoly Utca 1, 3300, Eger
Strazsahegy Medicina Bt.
N/A, Duna Sor 2, 2120, Dunakeszi
DRC Kft.
DRC Kft., Seregelyesi Ut 17, 8000, Szekesfehervar
Eszak-Budai Szent Janos Centrumkorhaz
II. belgyogyaszati - Diabetologiai osztaly, Dios Arok 1-3, 1125, Budapest XII
Studium Egeszseghaz Kft.
N/A, Szechenyi Ut 16 Fsz. 1, 6300, Kalocsa
University Of Debrecen
A epulet, Nagyerdei Korut 98, 4032, Debrecen
ASL To5
SC DIABETOLOGIA TERRITORIALE, Via Mari 1, 10023, Chieri
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UOC di Malattie Endocrine, del Ricambio e della Nutrizione, Via Del Vespro 129, 90127, Palermo
Universita' Degli Studi G. D'annunzio Di Chieti
Clinical research Center - CAST, Via Dei Vestini 31, 66100, Chieti
Centro Cardiologico Monzino S.p.A.
DIABETES, ENDOCRINE AND METABOLIC DISEASES UNIT, Via Carlo Parea 4, 20138, Milan
Careggi University Hospital
Unita` di Diabetologia e malattie metaboliche, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department of medical and surgical sciences, Via Pietro Albertoni 15, 40138, Bologna
Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb
UO Medicina Interna e Endocrinologia, Via Salvatore Maugeri 4, 27100, Pavia
Azienda Ospedaliero Universitaria Parma
UO Endocrinologia e Malattie del Metabolismo, Viale Antonio Gramsci 14, 43126, Parma
University Hospital Consorziale Policlinico
UOC Endocrinologia, Piazzale Giulio Cesare 11, 70124, Bari
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UOC Endocrinologia, Via Francesco Sforza 28, 20122, Milan
Azienda Socio Sanitaria Locale N 2 Della Gallura
Diabetologia, Via Bazzoni Sircana 2/2/a, 07026, Olbia
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola
UOC Endocrinology, Diabetology e Metabolic Diseases, Via Di Ponte Quattro Capi 39, 00186, Rome
Universita' Degli Studi Di Verona
UOC Endocrinologia, diabetologia e malattied del metabolismo, Piazzale Aristide Stefani 1, 37126, Verona
Ospedale Garibaldi
"Division of Endocrinology Dept. of Clinical and Experimental Medicine", Piazza Santa Maria Di Gesu, 95123, Catania
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Malattie cardiovascolari, della nutrizione e del metabolismo, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Mater Domini
Department of Clinical and Surgery Science, Viale Tommaso Campanella 115, 88100, Catanzaro
Azienda Ospedaliero Universitaria Pisana
Endocrinology, Via Paradisa 2, 56124, Pisa
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department of advanced medical and surgical sciences, Piazza Luigi Miraglia 2, 80138, Naples
Azienda Ospedaliera Papa Giovanni XXIII
"USC MALATTIE ENDOCRINE-‐DIABETOLOGIA", Piazza Oms 1, 24127, Bergamo
Universita' Degli Studi Di Roma Tor Vergata
UOC Endocrinology and Diabetes, Viale Oxford 81, 00133, Rome
Universitair Medisch Centrum Utrecht
Vascular Medicine Research, Heidelberglaan 100, 3584 CX, Utrecht
Saxenburgh Medisch Centrum
cardiologie, Jan Weitkamplaan 4a, 7772 SE, Hardenberg
Reinier de Graaf Groep
Research Department Cardiology, Reinier De Graafweg 5, 2625 AD, Delft
Rijnstate Ziekenhuis Stichting
N/A, Wagnerlaan 55, 6815 AD, Arnhem
Jeroen Bosch Ziekenhuis
N/A, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
Het Van Weel-Bethesda Ziekenhuis
Cardiology, Stationsweg 22, 3247 BW, Dirksland
Diakonessenhuis Stichting
Research Cardiologie, Bosboomstraat 1, 3582 KE, Utrecht
Amsterdam UMC
Vascular Medicine Clin Trial Unit, Meibergdreef 9, 1105, AZ Amsterdam
Amsterdam UMC
Internal Medicine, De Boelelaan 1117, 1081 HV, Amsterdam
EB FlevoResearch B.V.
N/A, Louis Armstrongweg 88, 1311 RL, Almere
Canisius Wilhelmina Hospital
Research Cardiologie, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Ziekenhuis Gelderse Vallei Stichting
Gelderse Vallei, Willy Brandtlaan 10, 6716 RP, Ede Gld
Stichting Treant Ziekenhuiszorg
Bethesda Diabetes Research Center, Dr. G.h. Amshoffweg 1, 7909 AA, Hoogeveen
Stichting Radboud University Medical Center
internal medicine, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Ziekenhuis Amstelland
Cardiologie, Laan Van De Helende Meesters 8, 1186 AM, Amstelveen
Slingeland Ziekenhuis
Cardiology, Kruisbergseweg 25, 7009 BL, Doetinchem
Sint Franciscus Vlietland Groep Stichting
cardiology, Kleiweg 500, 3045 PM, Rotterdam
Spaarne Gasthuis
Cardioreseach, Boerhaavelaan 22, 2035 RC, Haarlem
CenterMed Lublin
No Department, ul. Weteranow 46,, 20-044, Lublin
Futuremeds Sp. z o.o.
No Department, Ul. Sapiezynska 3, 00-215, Warsaw
Legeartis Poradnie Specjalistyczne Sp. z o.o.
No Department, Ul. Mlynowa 17, 15-404, Bialystok
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
No Department, Ul. Piotra Niedurnego 50 D, 41-709, Ruda Slaska
Centrum Medyczne Omedica Jaroslaw Opiela I Beata Opiela Sp. j.
No Department, Ul. Steszewska 41/4, 60-111, Poznan
Etg Warszawa Sp. z o.o.
No Department, Ul. Wynalazek 4, 02-677, Warsaw
Ośrodek Badań Klinicznych "METABOLICA" Lek. Robert Witek
Poradnia Chorób Metabolicznych, Najświętszej Marii Panny 9B,, 33-100, Tarnów
Salvia Lekston I Madej Sp. J.
No Department, Ul. Panewnicka 201/1, 40-772, Katowice
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
No Department, Ul. Rusznikarska 17, 31-261, Cracow
Gaja Poradnie Lekarskie Maciej Wiza
No Department, osiedle Orła Białego 103, 61-251, Poznań
Wojewodzki Zespol Specjalistycznej Opieki Zdrowotnej
No Department, Ul. Dobrzynska 21/23, 50-403, Wroclaw
NZOZ Medica
No Department, 4, Jutrzenki,, Lublin
Terpa Sp. z o.o. S.K.
No Department, Ul. Pogodna 34, 20-337, Lublin
Osrodek Diabetologiczny Popula Elzbieta Poplawska Grazyna Laszewska Sp. j.
No Department, Aleja Jozefa Pilsudskiego 4a Lok 1, 15-445, Bialystok
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
No Department, Ul. Przedzalniana 66, 90-338, Lodz
Private Practice - Dr. Ewa Krzyzagorska
No Department, Murawa 37a,, 61-655, Poznan,
NZOZ Regionalna Poradnia Diabetologiczna
Regionalna Poradnia Diabetologiczna, Ulica Świętego Mikołaja 53/1A,, 50-127, Wroclaw,
Instytut Diabetologii Sp. z o.o.
No Department, Ul. Raclawicka 129/2u, 02-117, Warsaw
Centrum Badan Klinicznych Pi-House Sp. z o.o.
NA, Ul. Na Zaspe 3, 80-546, Gdansk
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Diabetology, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Easydiet S.R.L.
Diabetes, nutrition and metabolic diseases, Strada Alexandrescu Grigore Nr 80 Sector 1, 010627, Bucharest
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
Diabetes, metabolic diseases, Strada Movila Ion 5-7, 020475, Bucharest
Dianutrilife Medica S.R.L.
Diabetes, nutrition and metabolic diseases, Strada Glinca Alexandru Nr. 37, 100561, Ploiesti
Gama Diamed S.R.L.
Diabetology, T S Saveanu Nr 1, 905500, Mangalia
Diabmed Dr. Popescu Alexandrina S.R.L.
Diabetes, nutrition and metabolic diseases, Strada Transilvaniei Nr.20, 100179, Ploiesti
Top Diabet S.R.L.
Diabetes, nutrition and metabolic diseases, Block D2 Staircase 3 Apartment 2, Strada Calea Bucuresti No 58, Craiova
Nutrilife S.R.L.
Diabetology, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest
CMI DNBM Dr. Pop Lavinia
Diabetes, nutrition and metabolic diseases, Strada George Cosbuc nr. 25A, Baia Mare, Baia Mare
Consultmed S.R.L.
Diabetes, nutrition and metabolic diseases, Block 550, Soseaua Pacurari 70, Jassi
Diabdana S.R.L.
Diabetes, nutrition and metabolic diseases, Calea Republicii Nr 77, 410147, Oradea
Dentosim-Queen S.R.L.
Diabetes, nutrition and metabolic diseases, Strada Mihai Viteazul 27a, 540098, Targu Mures
Olimpia Med S.R.L.
Diabetes, nutrition and metabolic diseases, Etaj 1 Cabinet 2, Strada Ghica Grigore Voda 7, Iasi
Sc Cmi Dr. Pletea Noemi S.R.L.
Diabetes, nutrition and metabolic diseases, Strada Stadionului Nr 3a Parter, 600154, Bacau
Grandmed S.R.L.
Diabetology, Calea Republicii Nr 32, Ap. 1, Oradea
Minimed S.R.L.
Diabetes, nutrition and metabolic diseases, Strada Bacovia George Nr 58, 600238, Bacau
Centrul Medical Dr.Negrisanu S.R.L.
Diabetes, nutrition and metabolic diseases, Floor 1 Apartment 3, Strada Transilvania Nr. 7, Timisoara
Nicodiab S.R.L.
Diabetes, nutrition and metabolic diseases, Strada Polona Nr 92, 010507, Bucharest
Diana Barbonta S.R.L.
Diabetes, nutrition and metabolic diseases, Block 4 Bcdef, Strada Closca Nr 6, Alba Iulia
Diamed Obesity S.R.L.
Diabetes, metabolic diseases, Gheorghe Doja Nr 73, 800291, Galati
Diabetes Centrum s.r.o.
Diabetologická ambulancia, Pod Brezinou 6402/82, 911 01, Trencin
Diabetol s.r.o.
Diabetologická ambulancia, Hlavna 60, 080 01, Presov
DIA MED CENTRUM s.r.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, Tajovskeho 8568/3, 010 01, Zilina
IN DIA s.r.o.
Interná a diabetologická ambulancia, Mierova 1, 984 01, Lucenec
Funkystuff s.r.o
Ambulancia diabetológie a porúch látkovej premeny a výživy, J. Krala 8760/3, 940 02, Nove Zamky
Medi-Dia s.r.o.
Diabetologická ambulancia Sabinov, Namestie Slobody 65, 083 01, Sabinov
DIAB s.r.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, Namestie 1. Maja 11, 048 01, Roznava
Diacrin s.r.o.
Ambulancia diabetológie, porúch látkovej premeny a výživy a endokrinológie, Kosicka 43/d, 821 08, Ruzinov
Sin Azucar s.r.o.
Diabetologická ambulancia, Ludovita Fullu 5274, 901 01, Malacky
Tatratrial s.r.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, Namestie 1. Maja 11, 048 01, Roznava
Area Sanitaria De Ferrol
Endocrinology, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitario La Paz
Cardiology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Principe De Asturias
Endocrinology, Carretera Meco S/n, 28805, Alcala De Henares
Hospital Universitario Y Politecnico La Fe
Endocrinology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Complexo Hospitalario Universitario A Coruna
Endocrinology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Virgen De Las Montanas
Internal Medicine, Paseo Ambulatorio Sn, 11650, Villamartin
Hospital Universitario Torrecardenas
Endocrinology, Calle Paraje Torrecardenas S/n, 04009, Almeria
Hospital Universitario Quironsalud Madrid
Endocrinology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De La Ribera
Internal Medicine, Carretera Corbera Km 1, 46600, Alzira
Hospital General Universitario De Valencia
Endocrinology, Avenida Del Tres Cruces 2, 46014, Valencia
Complexo Hospitalario Universitario De Santiago
Cardiology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Ramon Y Cajal
Internal Medicine, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Virgen Del Camino
Internal Medicine, Carretera De Chipiona Sn, 11540, Sanlucar De Barrameda
Hospital Universitario Virgen De La Victoria
Endocrinology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Endocrinology, Calle Alejo Fernandez 9, 41003, Sevilla
Hospital Universitario Virgen De Las Nieves
Endocrinology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario Virgen De La Macarena
Internal Medicine, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Central De Asturias
Endocrinology, Avenida De Roma S/n, 33011, Oviedo
Hospital Clinico Universitario De Valladolid
Endocrinology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Quironsalud Infanta Luisa
Internal Medicine, Calle De San Jacinto 87, 41010, Sevilla
Lundberg Laboratory Diabetes research Sahlgrenska Universitetssjukhuset
Department of internal medicine, Sahlgrenska Universitetssjukhuset Blå Stråket 5, 413 45, Göteborg
ProbarE i Lund AB
N/A, S Domkyrkofors., Lilla Fiskaregatan 10, Lund
Ostersund Sjukhus
Department of Public Health and Clinical Medicine, KSC-Z plan 6 Läkemedelsstudier Östersund Sjukhus, Kyrkgatan 14, Östersund
Citydiabetes, Serafen
N/A, Hantverkagatan 2D, 112 21, Stockholm
Dalecarlia Clinical Research Center
N/A, Torggatan 18, 795 30, Rättvik
AKP - Avdelningen for Kliniska Provningar
Department for Clinical Trials - Avdelningen for Kliniska Provningar, Universitetssjukhuset Örebro, S-huset, Örebro
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 | 2020-06-29 | 2025-05-26 | 2020-06-30 | 2022-08-05 | |
| Belgium | 2020-06-30 | 2025-05-15 | 2020-07-27 | 2022-08-05 | |
| Czechia | 2020-06-26 | 2025-05-27 | 2020-07-08 | 2022-08-05 | |
| France | 2020-06-19 | 2025-06-05 | 2020-06-22 | 2022-08-05 | |
| Germany | 2020-07-08 | 2025-06-12 | 2020-07-09 | 2022-08-05 | |
| Greece | 2020-06-30 | 2025-05-29 | 2020-07-01 | 2022-08-05 | |
| Hungary | 2020-08-19 | 2025-05-30 | 2020-08-27 | 2022-08-05 | |
| Italy | 2020-07-31 | 2025-05-28 | 2020-08-04 | 2022-08-05 | |
| Netherlands | 2020-09-17 | 2025-05-26 | 2020-10-06 | 2022-08-05 | |
| Poland | 2020-07-27 | 2025-05-29 | 2020-07-30 | 2022-08-05 | |
| Romania | 2020-07-21 | 2025-05-29 | 2020-07-27 | 2022-08-05 | |
| Slovakia | 2020-07-03 | 2025-05-21 | 2020-07-08 | 2022-08-05 | |
| Spain | 2020-07-15 | 2025-06-02 | 2020-07-23 | 2022-08-05 | |
| Sweden | 2020-08-21 | 2025-05-28 | 2020-08-24 | 2022-08-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 231 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | Blank document Template_GPGN | 1 |
| Recruitment arrangements (for publication) | Blank document Template_GPGN | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 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 | 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 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of sites_Clean_CZ_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of sites_Track changes_CZ_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements. | 1.0 |
| Recruitment arrangements (for publication) | K2_List of participating sites | 2 |
| Recruitment arrangements (for publication) | K2_List of paticipating sites_SK_SM-7_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | Blanket Statement - Document not published anymore | 1.0 |
| Subject information and informed consent form (for publication) | L1_Addendum ICF_DTP_GR | 1 |
| Subject information and informed consent form (for publication) | L1_Addendum_Retinopathy_ ICF_GR | 1 |
| Subject information and informed consent form (for publication) | L1_Addendum_Retinopathy_ICF_GR | 1 |
| Subject information and informed consent form (for publication) | L1_Country Reimbursement and Reminder ICF_GR | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum 7 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum 7_1 | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Main_FRE_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_ICF_Greenphire | 1 |
| Subject information and informed consent form (for publication) | L1_Informed consent form_Country_Specific_Main ICF_CZ | 6.0 |
| Subject information and informed consent form (for publication) | L1_Informed consent form_ICF_Data Privacy Addendum_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_Informed consent form_ICF_Reimbursement_CZ_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_Informed consent form_Site-Specific ICF attach_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L1_Informed consent form_Site-Specific ICF_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L1_Informed consent form_Site-Specific Reimbursement_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Summary_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_Informed consent form_Summary_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF BEDU Clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF BEDU TC_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF BEFR Clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF BEFR TC_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF ENG Clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF ENG TC_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_GR | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Summary of changes_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Pregnant Participant ICF _BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Participant ICF_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Participant ICF_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_GR | 1 |
| Subject information and informed consent form (for publication) | L1_RO_ICF Genetic_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_ICF Greenphire_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_ICF Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_RO_Informed Consent Amendment Summary_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF_Tracked changes | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement ICF_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement ICF_Tracked changes_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Retinopathy_v1.0_29Dec2020 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Retinopathy_v2.0_03Jul2023 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of changes 1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum 7 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum 7.1 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GP Letter_Clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement and Reminder Addendum ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes SoC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Main_Summary of Changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Greenphire Travel Contact Card_v2 July 2016_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Greenphire_Fee_Schedule_V3_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_EC packet w Data Privacy as applied to GP v4_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire ClinCard Msg Templates - ROW_v6 Feb 2018 | 6.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire ClinCard Travel Ref Guide for Subjects_v3 Oct 2016 | 3.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ClinCard_Card_Carrier_V1 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ClinCard_Cardholder_FAQ_EU_V2 | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Communication ICF Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material EC packet w Data Laws as applied to GP | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Glucometer Manual | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire ClinCard Card Carrier | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire ClinCard Card Carrier_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire ClinCard Cardholder FAQ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire ClinCard Cardholder FAQ_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire ClinCard Msg Templates | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire ClinCard Msg Templates - ROW | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire ClinCard Travel Ref Guide for Subjects | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire ClinCard Travel Ref Guide for Subjects_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire EC Submission Overview | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire Fee Schedule | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire Fee Schedule _Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire GDPR Statement | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire Travel Contact Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material IFU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Information Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Retention Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Thank you Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Patient Information Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Pen use guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_accu check guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Accu-check guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Accu-Chek Guide Manual ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Accu-Chek Guide Manual FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Accu-Chek Guide QSG ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Accu-Chek Guide QSG DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Accu-Chek Guide QSG FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Accu-Chek Instant_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_AccuChek Guide Manual DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Ancillary Supply List_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_AppointementCard FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appointment Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Appointment Card | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_AppointmentCard DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Appreciation item list | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Appreciation items | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Items List_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Items List_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Items List_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation items_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clinical Trial Ancillary Supply List_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clinical Trial Ancillary Supply List_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clinical Trial Ancillary Supply List_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Device Manual | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Diarrhea Info | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Diarrhoea Guidelines | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_FACT Card | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_FactCard Diarrhoea DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_FactCard Diarrhoea FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_FactCard Hypoglycemia DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_FactCard Hypoglycemia FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fundoskopie CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Greenphire ClinCard Travel Ref Guide_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic ClinCard | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Greenphire Fee Schedule_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Greenphire IRB Submission overview | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Greenphire message | 6 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Greenphire Template Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Greenphire Travel Contact Card_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Greenphire_Carrier | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Greenphire_ClinCard_Cardholder_FAQ | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Accu-Chek Instant QSG_Lit | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_AccuChek Instant Manual_Lit | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Appointment card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Fact Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Hypoglycemia factscard | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Log Sheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Thank you card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Visit guide | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HYPO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HYPO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Hypo Log | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Hypo Tool | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Hypoglycaemia reporting Log | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Hypoglycaemia reporting Log | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Hypoglycemia Info | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Hypoglycemia LogSheet DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Hypoglycemia LogSheet FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Instruction for Use | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Instructions for use DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Instructions for use ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Instructions for use FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Log Sheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Manual Pen | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card Layout | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Patient Emergency Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Thank you letter_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card_SK | 2.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_TC_SURPASS-CVOT_FV_Patient_Thank you letter BEDU | 2.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_TC_SURPASS-CVOT_FV_Patient_Thank you letter BEFR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank you card | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Thank You Card_Du | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Thank You Card_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you card_IT | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank you letter | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you letter_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank you letter_track changes | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_visit guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_visit Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit guide | 1,0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Visit Guide | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_VisitGuide DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_VisitGuide FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_visits card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Welcome letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material-Note Book | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information Retention Materials_FACT_CARD | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Retention Materials_Hypo Tool | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Retention Materials_LOG_SHEET | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Retention Materials_Visit Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Retention Materials_Visit Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient cards | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Facing document_Pt card_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Reimbursement_Greenphire EU Generic ClinCard | 3 |
| Subject information and informed consent form (for publication) | L2_Patient Reimbursement_Greenphire_ClinCard_Cardholder_FAQ_EU | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Reimbursement_Greenphire_Fee Schedule_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Patient Reimbursement_Greenphire_Infoblatt fuer Patienten | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Reimbursement_Greenphire_Leitfaden zu klinischen Reisen_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Reimbursement_Greenphire_Reisekontaktkarte_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Reimbursement_Greenphire_Vorlage Greenphire EU Generic ClinCard | 6 |
| Subject information and informed consent form (for publication) | L3_Direction for use__Accu-Chek Instant_Lit 07946155001_RO | 2.0 |
| Subject information and informed consent form (for publication) | L3_Direction for use_Accu-Chek Instant QSG_Lit 07946198001 | 1.0 |
| Subject information and informed consent form (for publication) | L3_Direction for use_IFU_RO_30Aug2019 | 1.0 |
| Subject information and informed consent form (for publication) | L3_Justification of collection of race and ethnicity_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L3_Other subject information__Thank you letter for participants_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L3_Other subject information_Appreciation-Items_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient Emergency Card_RO | 1.0 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_Greenphire ClinCard Msg Templates | 6.0 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_Greenphire_ClinCard Cardholder_FAQ | 2.0 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_Greenphire_ClinCard Travel Ref Guide for Subjects_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_Greenphire_ClinCard_Card_Carrier | 1.0 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_Greenphire_Fee_Schedule_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_Greenphire_Travel Contact Card_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L4_Patient card_HU | 1.0 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_HU | 1.0 |
| Subject information and informed consent form (for publication) | L6_List of Submitted Part II Documents | 1 |
| Subject information and informed consent form (for publication) | RFI-CT-2023-507846-96-00-SM02-001-10 ERBs_RA Communication ICF Summary of Changes_redacted signed | 1 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-06 | Germany | Acceptable 2023-11-15
|
2023-11-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-17 | Germany | Acceptable 2024-04-12
|
2024-04-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-31 | Germany | Acceptable 2024-08-27
|
2024-08-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-18 | Acceptable 2024-08-27
|
2024-10-18 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-21 | Acceptable | 2024-12-02 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-25 | Acceptable | 2024-12-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-14 | Acceptable | 2025-01-07 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-05 | Acceptable | 2025-01-13 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-12-17 | Acceptable | 2025-02-18 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-20 | Acceptable | 2025-02-18 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-03-27 | Acceptable | 2025-05-08 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-04-23 | Germany | Acceptable | 2025-06-04 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-04 | 2025-06-04 | ||
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-24 | 2025-11-24 |