- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05018585
A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes (DIAGNODE-3)
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults With Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Chief Operating Officer
- Phone Number: +46 (0) 8 661 00 26
- Email: clinicaltrials@diamyd.com
Study Locations
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Jihlava, Czechia, 586 01
- Recruiting
- Nemocnice Jihlava, příspěvková organizace
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Contact:
- Pavel Vlachý
- Phone Number: +420 567 157 400
- Email: vlachyp@nemji.cz
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Prague, Czechia, 140 21
- Recruiting
- Institut Klinicke A Experimentalni Mediciny
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Contact:
- Zuzana Vlasáková
- Phone Number: +420 605 238 015
- Email: zuvl@ikem.cz
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Contact:
- Radomíra Kožnarová
- Phone Number: +420 605 981 991
- Email: radomira.koznarova@ikem.cz
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Prague, Czechia, 150 06
- Recruiting
- Fakultni nemocnice v Motole
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Contact:
- Zdeněk Šumník
- Email: zdenek.sumnik@lfmotol.cuni.cz
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Contact:
- Lukáš Plachý
- Email: Lukas.plachy@fnmotol.cz
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Ústí Nad Labem, Czechia, 400 13
- Recruiting
- Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
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Contact:
- Jaroslav Škvor
- Email: diadeti.ul@kzcr.eu
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Contact:
- Lucie Štíchová
- Phone Number: +420 477 112 355
- Email: Lucie.Stichova@kzcr.eu
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Pärnu, Estonia, 80018
- Recruiting
- Liina Viitas OÜ
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Contact:
- Liina Viitas, Dr.
- Phone Number: +372 513 62 20
- Email: viitas@hotmail.com
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Tallinn, Estonia, 13419
- Recruiting
- North-Estonian Regional Hospital
-
Contact:
- Anu Ambos, Dr.
- Phone Number: +372 525 42 13
- Email: anu.ambos@regionaalhaigla.ee
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Contact:
- Ülle Einberg, Dr.
- Phone Number: +372 534 24 144
- Email: ylle.einberg@lastehaigla.ee
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Tartu, Estonia, 50406
- Recruiting
- Tartu University Hospital
-
Contact:
- Maire Lubi, Dr.
- Phone Number: +372 524 76 57
- Email: maire.lubi@kliinikum.ee
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Tartu, Estonia, 51014
- Recruiting
- Tartu University Hospital, Children's Clinic
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Contact:
- Aleksandr Peet, Dr.
- Phone Number: +372 731 96 05 (14:00-15:00)
- Email: aleksandr.peet@kliinikum.ee
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Berlin, Germany, 131 87
- Recruiting
- Diabetespraxis Dr. Braun
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Contact:
- Daniela Bettin
- Email: bettin@diabetespraxis-braun.de
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Contact:
- Hermann Braun, Dr.
- Phone Number: +49 3023 59 89 34 8
- Email: drhermannbraun@aol.com
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Dortmund, Germany, 441 37
- Recruiting
- Diabetologische Schwerpunktpraxis Dres. Klaus
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Duisburg, Germany, 470 51
- Recruiting
- DZDM - Diabeteszentrum Duisburg Mitte
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Giessen, Germany, 353 92
- Recruiting
- Justus-Liebig-Universität Gießen
-
Contact:
- Thomas Linn, Dr.
- Phone Number: +49 641 985 57017
- Email: Thomas.linn@innere.med.uni-giessen.de
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Budapest, Hungary, 1036
- Recruiting
- Óbudai Egészségügyi Centrum
-
Contact:
- Viktor Vass, Dr.
- Phone Number: 06 70 450 8040
- Email: vassviktor@yahoo.com
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Budapest, Hungary, 1125
- Recruiting
- Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő, II. Belgyógyászat
-
Contact:
- János Tibor Kis, Dr.
- Phone Number: 06 70 316 4996
- Email: kis.janos.tibor.dr@gmail.com
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Budapest, Hungary, 1089
- Recruiting
- Heim Pál Országos Gyermekgyógyászati Intézet, Diabetológia
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Contact:
- Zsuzsanna Almássy, Dr.
- Phone Number: 06 30 977 0577
- Email: almassyzs@gmail.com
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Nyíregyháza, Hungary, 4400
- Recruiting
- Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi, Oktatókórház, Jósa András Oktatókórház, Gyermekosztály
-
Contact:
- Irén Kántor, Dr.
- Phone Number: 06 20 458 3828
- Email: kantoriren@vipmail.hu
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Szombathely, Hungary, 9700
- Recruiting
- Markusovszky Egyetemi Oktatókórház, Diabetológiai Szakrendelés
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Contact:
- Marietta Baranyai, Dr.
- Email: diabetologia@markusovszky.hu
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Contact:
- Dora Horvath, Dr.
- Phone Number: +36309299385
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-
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Amsterdam, Netherlands, 1105 AZ
- Recruiting
- Amsterdam UMC, Academic Medical Center (AMC)
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Contact:
- Diona Zwirs
- Phone Number: +31 205 666 638
- Email: d.zwirs@amsterdamumc.nl
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Dordrecht, Netherlands, 3318 AT
- Recruiting
- Albert Schweitzer Ziekenhuis
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Contact:
- Joyce Olsthoorn
- Phone Number: +31 786 545 134
- Email: j.olsthoorn@asz.nl
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Hoogeveen, Netherlands, 7909 AA
- Recruiting
- Bethesda Diabetes Research Center te Hoogeveen
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Leiden, Netherlands, 2333 ZA
- Recruiting
- Dept. of Nephrology / Dept. of Endocrinology, Leiden University Medical Center (LUMC)
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Contact:
- Klinische Research Unit Interne Geneeskunde
- Phone Number: +31 715 263 665
- Email: research_interne@lumc.nl
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Nijmegen, Netherlands, 6532 CL
- Recruiting
- Vivendia
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Contact:
- Cathelijne van de Sande
- Phone Number: +31 24-3658736 (keuze 2)
- Email: Vivendia@cwz.nl
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Rotterdam, Netherlands, 3011 TA
- Recruiting
- Diabeter Nederland te Rotterdam
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Contact:
- Theo Sas, Dr.
- Phone Number: +31 882 807 277
- Email: onderzoek@diabeter.nl
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Contact:
- Katja Zuur
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Bialystok, Poland, 15-274
- Recruiting
- Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku, Klinika Pediatrii, Endokrynologii, Diabetologii z Pododdziałem Kardiologii
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Contact:
- Barbara Olszewska-Glowinska, Professor
- Phone Number: 85 745 07 32
- Email: barbara.glowinska-olszewska@umb.edu.pl
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Gdańsk, Poland, 80-952
- Recruiting
- Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Diabetologii i Endokrynologii
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Contact:
- Matylda Hennig, Dr n. med.
- Phone Number: 58 349 28 90
- Email: mhennig@gumed.edu.pl
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Contact:
- Małgorzata Szmigero-Kawko, Dr. n. med.
- Email: mkawko@gumed.edu.pl
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Kraków, Poland, 30-688
- Recruiting
- SP ZOZ Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Chorób Metabolicznych i Diabetologii
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Contact:
- Tomasz Klupa, Prof. dr hab. n. med.
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Contact:
- Paweł Janas
- Phone Number: 12 400 38 87
- Email: pjanas@su.krakow.pl
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Lublin, Poland, 20-538
- Recruiting
- NZOZ Przychodnia Specjalistyczna Medica
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Contact:
- Ewa Skokowska, Lek.
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Contact:
- Paulina Sidor
- Phone Number: 694 991 176
- Email: paaulina.nowa90@gmail.com
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Poznań, Poland, 60-111
- Recruiting
- Centrum Medyczne OMEDICA
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Contact:
- Jarosław Opiela, Lek.
- Email: info@omedica.pl
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Contact:
- Karolina Kulbiej
- Phone Number: 728 839 274
- Email: kulbiejkarolina@gmail.com
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Rzeszów, Poland, 35-301
- Recruiting
- Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie, II Klinika Pediatrii, Endokrynologii i Diabetologii Dziecięcej
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Contact:
- Artur Mazur, Prof. dr hab. n. med.
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Contact:
- Katarzyna Jakubek-Kipa, Lek.
- Phone Number: 17 86 64 636
- Email: endokrynologia.dzieci@szpital2.rzeszow.pl
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Warsaw, Poland, 02-117
- Recruiting
- Instytut Diabetologii Sp. z o.o
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Contact:
- Ewa Pańkowska, Prof. dr hab. n. med.
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Contact:
- Marta Puchalska
- Phone Number: 500 336 605
- Email: marta.puchalska@instytutdiabetologii.pl
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Warsaw, Poland, 04-730
- Recruiting
- Instytut Pomnik - Centrum Zdrowia Dziecka (IPCZD) Oddział Diabetologii
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Contact:
- Marta Wysocka-Mincewicz, Dr hab. n. med
- Email: m.wysocka@ipczd.pl
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Contact:
- Jerzy Wakuliński, Lek.
- Phone Number: 22 815 77 82
- Email: j.wakulinski@ipczd.pl
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Warsaw, Poland, 02-507
- Recruiting
- Panstwowy Instytut Medyczny MSWiA Klinika Chorob Wewnetrznych, Endokrynologii i Diabetologii
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Contact:
- Edward Franek, Prof. dr hab. n. med.
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Contact:
- Agnieszka Górna
- Phone Number: 47 722 20 12
- Email: agnieszka.gorna@cskmswia.gov.pl
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Barakaldo, Spain, 48903
- Recruiting
- Hospital de Cruces
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Contact:
- Itxaso Rica Echevarria
- Phone Number: +34 946 006 313
- Email: itxaso.ricaechevarria@osakidetza.eus
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitari Vall d'Hebron
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Contact:
- Mercè Abad
- Phone Number: +34 671 670 022
- Email: merce.abad@vhir.org
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Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic de Barcelona
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Contact:
- Antonio Jesus Blanco Carrasco
- Phone Number: +34 932 279 846
- Email: endotrials@clinic.cat
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Barcelona, Spain, 08950
- Recruiting
- Hospital de Sant Joan de Déu - Esplugues De Llobregat, Barcelona
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Contact:
- Roque Cardona-Hernandez
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Contact:
- Sara Darriba-Jimenez
- Phone Number: +34 687 259 778
- Email: sara.darriba@sjd.es
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Girona, Spain, 17007
- Recruiting
- Hospital Universitari de Girona Dr. Josep Trueta
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Contact:
- Merce Fernandez Balsells
- Email: mercefernandez.girona.ics@gencat.cat
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Contact:
- Javier Castells
- Phone Number: +34 872 987087 extension 323
- Email: jcastells@idibgi.org
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Las Palmas, Spain, 35016
- Recruiting
- Complejo Hospitalario Insular de Gran Canaria
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Contact:
- Yaiza Gil
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Contact:
- Phone Number: +34 928 441617
- Email: erui-chuimi.scs@gobiernodecanarias.org
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Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon y Cajal
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Contact:
- Maria Nattero Chavez
- Phone Number: +34 635 249 182
- Email: marialia.nattero@salud.madrid.org
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Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
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Contact:
- Unidad de Ensayos Clinicos
- Phone Number: +34 912 071 876
- Email: ucicec.hulp@salud.madrid.org
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Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Maranon
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Contact:
- Alba Galdón Sanz-Pastor
- Phone Number: +34 915 866 679
- Email: albagaldonsp@gmail.com
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Málaga, Spain, 29010
- Recruiting
- Hospital Regional Universitario de Málaga
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Contact:
- Maria Soledad Ruiz de Adana
- Phone Number: +34 951290305 / +34670941176
- Email: unidadeeccendocrino@gmail.com
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Sevilla, Spain, 41009
- Recruiting
- Hospital Universitario Virgen Macarena
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Contact:
- María Luisa García
- Phone Number: +34 955 006 685
- Email: mlgg.investigacionmacarena@hotmail.com
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Valencia, Spain, 46014
- Recruiting
- Hospital General Universitario de Valencia
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Contact:
- Juan Carlos Ferrer Garcia
- Email: ferrer_juagar@gva.es
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Contact:
- Raquel Albalat
- Phone Number: +34 963 131 800 ext. 438608
- Email: albalat_raq@gva.es
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Skåne
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Malmö, Skåne, Sweden, 20502
- Recruiting
- Skanes Universitetssjukhus
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Contact:
- Ulrika Ulvenhag
- Phone Number: +46040391121
- Email: ulrika.ulvenhag@med.lu.se
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Stockholms Län
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Stockholm, Stockholms Län, Sweden, 102 35
- Recruiting
- Akademiskt Specialistcentrum, Centrum for Diabetes
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Contact:
- Anneli Björklund
- Email: anneli.bjorklund@ki.se
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Västerbotten
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Umeå, Västerbotten, Sweden, 901 85
- Recruiting
- Barn-och Ungdomscentrum Västerbotten, Norrlands Universitetssjukhus
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Contact:
- Camilla Ernstsson
- Phone Number: +46907852159
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Östergötland
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Linköping, Östergötland, Sweden, 581 85
- Recruiting
- H.K.H Kronprinsessan Victorias Barn-och Ungdomssjukhus, Universitetssjukhuset i Linköping
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Contact:
- Petra Liljeblad Morgård
- Phone Number: +46101031307
- Email: petra.liljeblad.morgard@regionostergotland.se
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California
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Newport Beach, California, United States, 92663
- Recruiting
- Mary & Dick Allen Diabetes Center at Hoag Hospital
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Contact:
- Brittany Dennis
- Phone Number: 949-764-6896
- Email: brittany.dennis@hoag.org
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Contact:
- David Ahn, Dr.
- Email: david.ahn@hoag.org
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Palo Alto, California, United States, 94304
- Not yet recruiting
- Stanford University School of Medicine Center for Academic Medicine
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San Diego, California, United States, 92123
- Not yet recruiting
- UCSD/ Rady Children's Hospital
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Contact:
- Marla Hashiguchi
- Phone Number: 858-966-8940
- Email: mhashiguchi@rchsd.org
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Contact:
- Ron Newfield, Dr.
- Email: rnewfield@rchsd.org
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Colorado
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Aurora, Colorado, United States, 80045
- Not yet recruiting
- University of Colorado Anschutz Medical Campus, Barbara Davis Center for Childhood Diabetes
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Contact:
- Taylor Triolo, Dr.
- Email: taylor.triolo@cuanschutz.edu
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Contact:
- Fatima Tensun
- Phone Number: 303-724-0064
- Email: fatima.tensun@cuanschutz.edu
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Florida
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Miami, Florida, United States, 33136
- Recruiting
- Diabetes Research Institute (DRI)-University of Miami Leonard M. Miller School of Medicine (UMMSM)
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Contact:
- David Baidal, Dr.
- Email: dbaidal@med.miami.edu
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Contact:
- Carlos Baschke, Dr.
- Phone Number: 305-243-4485
- Email: cblaschke@med.miami.edu
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Recruiting
- Rocky Mountain Diabetes and Osteoporosis Center
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Contact:
- Joshua Smith, Dr
- Phone Number: 208-528-9650
- Email: jms-research@idahomed.com
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Contact:
- Joann Malone
- Email: joann@idahomed.com
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Iowa
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Iowa City, Iowa, United States, 52242
- Not yet recruiting
- University of Iowa Hospital and Clinics
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Contact:
- Joann Malone
- Email: joann@idahomed.com
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Contact:
- Michael Tansey, Dr.
- Phone Number: 208-528-9650
- Email: michael-tansey@uiowa.edu
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Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University
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Contact:
- Thomas Donner, Dr.
- Email: tdonner1@jhmi.edu
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Contact:
- Alexis Thomas
- Phone Number: 443-814-9385
- Email: diagnode3study@jh.edu
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Not yet recruiting
- Joslin Diabetes Center
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Contact:
- David Kim
- Phone Number: 888-813-8669
- Email: T1DTrials@joslin.harvard.edu
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Contact:
- Jason Gaglia, Dr.
- Email: jason.gaglia@joslin.harvard.edu
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Missouri
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Saint Louis, Missouri, United States, 63110
- Not yet recruiting
- Washington University Diabetes Center at Barnes Jewish Hospital
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Contact:
- Janet McGill, Dr.
- Email: jmcgill@wustl.edu
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Contact:
- Cameron Smith
- Phone Number: 314-747-5371
- Email: camerons@wustl.edu
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Texas
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San Antonio, Texas, United States, 78237
- Recruiting
- Diabetes & Glandular Disease Clinic
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Contact:
- Mark Kipnes, Dr
- Email: MKIPNES@dgdclinic.com
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Contact:
- Terri Ryan
- Phone Number: 210-614-8612 ext 1630
- Email: terri.ryan@dgdclinic.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients are eligible to be included in this study only if all of the following criteria apply:
- Must be capable of providing written, signed, and dated informed consent; and for patients who are minors, age-appropriate assent (performed according to local regulations) and parent/caregiver consent.
- Males and females aged ≥12 and <29 years old at the time of Screening.
- Diagnosed with T1D (according to the American Diabetes Association [ADA] classification) ≤6 months at the time of Screening.
- Possess the HLA DR3-DQ2 haplotype (all patients will be tested; prior genetic testing results will not be accepted).
Fasting C-peptide ≥0.12 nmol/L (≥0.36 ng/mL) on at least one occasion (maximum two tests on different days during the Screening period).
(US ONLY): Fasting C-peptide ≥0.12 - ≤1.5 nmol/L (≥0.36 - ≤4.5 ng/mL) on at least one occasion (maximum two tests on different days during the Screening period).
- Possess detectable circulating GAD65 antibodies (lowest level of detection defined by the method used by the central laboratory).
- Possess HbA1c levels between 35 to 80 mmol/mol (5.4 to 9.5%) on at least one occasion prior to randomization (maximum one additional test within one month from Visit 1B).
- Be on a stable insulin dose or insulin dosing regimen for one month prior to inclusion with limited fluctuation of daily insulin requirement based on investigator's assessment. For example, if the average insulin dose/kg/24h over a 7-day period compared to the previous 7-day period does not vary more than approximately 15% and/or if the daily insulin dose does not vary more than 0.1 U/kg/24h, the dose can be considered stable. Individuals that are diagnosed with T1D according to the ADA classification but are not taking insulin are eligible to participate.
- i. Females of childbearing potential (FOCBP) must agree to avoid pregnancy and have a negative pregnancy test performed at the required study visits.
FOCBP must agree to use highly effective contraception, during treatment and, until 90 days after the last administration of study medication. Birth control methods, which may be considered as highly effective (e.g., a failure rate of less than 1% per year when used consistently and correctly) include:
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Oral.
- Intravaginal.
- Transdermal.
Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral.
- Injectable.
- Implantable.
- Intrauterine device.
- Intrauterine hormone-releasing system.
- Bilateral tubal occlusion.
- Vasectomized partner (vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FOCBP trial patient and that the vasectomized partner has received medical assessment of the surgical success).
Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient).
9. ii. Male patients must agree to remain abstinent from heterosexual sex during treatment and for 90 days after treatment or, if sexually active, to use two effective methods of birth control (e.g., male uses a condom and female uses contraception) during and for 90 days after treatment. Acceptable male contraception is as follows:
- Condom (male).
- Abstinence from heterosexual intercourse.
- Vasectomy. The agreement to remain abstinent or use two effective methods of birth control will be clearly defined in the informed consent; the patient or legally authorized representatives (e.g., parents, caregivers, or legal guardians) must sign this specific section.
Exclusion Criteria:
Patients are not eligible to be included in this study if any of the following criteria apply:
- Participation in any other trial aimed to influence beta cell function from time of diagnosis of T1D.
- Treatment with any oral or non-insulin injectable anti-diabetic medication within 3 months prior to Screening.
- History of maturity-onset diabetes of the young (MODY).
- Pancreatic surgery, chronic pancreatitis, or other pancreatic disorders that could result in decreased beta cell capacity (e.g., pancreatogenous diabetes).
History of DKA or severe hypoglycemia requiring hospitalization within one month before Screening, or severe episodes of hypoglycemia requiring third party assistance within one month before Screening.
(US ONLY) Occurrence of DKA or severe hypoglycemia requiring hospitalization in the period of 90 days prior to Randomization (Visit 2).
- Signs or symptoms suggesting very poorly controlled diabetes e.g., ongoing weight loss, polyuria or polydipsia.
Hematologic condition that would make HbA1c uninterpretable including:
- Hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis.
- Donation of blood or blood products to a blood bank, blood transfusion or participation in a clinical study requiring withdrawal of >400 mL of blood during the 8 weeks prior to the Screening visit.
- Significant iron deficiency anemia.
- Heart malformations or vaso-occlusive crisis (VOC) leading to increased turnover of erythrocytes.
- (US ONLY) Abnormal hematology results at the time of Screening, specifically any of the following: white blood cells: Female 12-18 y < 5.5 x 109/L or >9.3 x 109/L, Male 12-18 y < 5.2 x 109/L or >9.7 x 109/L, Adults >18 y < 3.5 x 109/L or >11.1 x 109/L; platelets: Female 12-18 y < 192 x 109/L or > 307 x 109/L, Male 12-18 y < 180 x 109/L or > 299 x 109/L, Adults >18 y < 150 x 109/L or >400 x 109/L; hemoglobin: Female 12-18 y < 11.3 g/dL or > 13.4 g/dL, Male 12-18 y < 11 g/dL or >14.3 g/dL, Female >18 y < 11.5 g/dL or > 15.5 g/dL, Male >18 y < 13.2 g/dL or > 17 g/dL.
- Treatment with marketed or over-the-counter Vitamin D at the time of Screening and unwilling to abstain from such medication during the 120 days when the patient will be supplemented with the study-provided Vitamin D. A patient currently taking Vitamin D at the time of Screening must be willing to switch to the study-provided Vitamin D treatment and to administer it per the study requirements.
- (US ONLY) History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D.
- Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel).
- Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first study dose of study drug; or planned treatment with any vaccine up to 4 weeks after the last injection with study drug.
- Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
- Recent (past 12 months) or current treatment with immunosuppressant therapy, including chronic use of glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable. Short courses (e.g., ≤5 days) of oral or intra-articular injections of steroids will be permitted on trial.
- Continuous/chronic treatment with prescribed or over-the-counter anti-inflammatory therapies. Short-term use (e.g., <7 days) is permissible, for example to treat a headache or in connection with a fever.
- Known or suspected acute infection, including COVID-19 or influenza, at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a negative polymerase chain reaction test will be required before randomization.
- A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles.
- Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Patients with previous hepatitis C infection that is now cured may be eligible.
Any clinically significant concomitant medical condition, including but not limited to other autoimmune diseases, cardiovascular, gastrointestinal, hematological, immune, renal including a history of renal transplantation, neurological (including Batten disease), significant diabetes complication, any underlying conditions or receiving treatments that could affect red blood cell turnover or other diseases that in the opinion of the investigator would interfere with trial participation or procedures. Celiac disease with adequate diet before diagnosis or discovered by increased autoantibodies at Screening will be permitted.
(US ONLY) Any clinically significant concomitant medical condition, including but not limited to other autoimmune or immune deficiency diseases (e.g., sarcoidosis, rheumatoid arthritis, moderate-to-severe psoriasis, inflammatory bowel disease, and other autoimmune conditions that may require treatment with TNF-alpha inhibitors or other biologics), gastrointestinal, hematological, or renal diseases including a history of any organ transplant (including renal transplantation and islet transplantation), neurological disease (including Batten disease); significant diabetes complication; a history of adrenal insufficiency; any underlying conditions or receiving treatments that could affect red blood cell turnover or other diseases that interfere with trial participation or procedures. Celiac disease with adequate diet before diagnosis or discovered by increased autoantibodies at Screening will be permitted, as well as autoimmune thyroid disease under certain conditions (see Exclusion Criterion #23).
- Significant cardiovascular disease (including inadequately controlled hypertension [resting blood pressure >140/90 mmHg despite treatment], history of myocardial infarction, angina, use of anti-anginal medicines [e.g., nitroglycerin], or abnormal cardiac stress test.
- History of significant hepatic disease or Screening alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) or aspartate aminotransferase (AST) 3 x ULN and/or total bilirubin >2 x ULN. Patients with documented Gilbert syndrome and total bilirubin level ≥2 x ULN due to unconjugated hyperbilirubinemia, without other hepatic impairment, are permitted.
- Estimated glomerular filtration rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) for those >18 years, or by the Schwartz equation for those 12 to 18 years old, <90 mL/min per 1.73 m or rapidly progressing renal disease.
Patients with hypothyroidism or hyperthyroidism must be on stable treatment for at least 3 months prior to Screening (with normal free thyroxine [T4] levels if hypothyroid).
(US ONLY) Patients with hypothyroidism or hyperthyroidism must be on stable treatment for at least 3 months prior to Screening (with normal free thyroxine [T4] levels if hypothyroid). A thyroid-stimulating hormone (TSH) level > 1.5 times the ULN at Screening is an exclusion criterion.
Any clinically significant abnormal findings during Screening, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or ability to complete the trial.
(US ONLY) Any clinically significant abnormal findings during Screening, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or ability to complete the trial. This includes anticipated major surgery during the duration of the trial, which could interfere with participation in the trial.
- History of malignancy not in remission within the last 5 years other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
- Patients with any mental condition rendering him/her unable to understand the nature, scope and possible consequences of the trial, and/or evidence of poor compliance with medical instructions at Screening or showing non-compliance during the Run-In Period.
- A history of alcohol or drug abuse or dependence within the past 12 months based on DSM IV criteria.
- Current or previous participation in a trial of Diamyd.
- Participation in a clinical trial involving administration of an investigational drug in the past 3 months or 5 half-lives (whichever is longer) prior to first dosing of study drug or during the trial.
- Females who are breastfeeding, pregnant or plan to become pregnant during the trial.
- Patients who in the opinion of the investigator will not be able to follow instructions and/or follow the study procedures or patients that are unwilling or unable to comply with the provisions of this protocol.
- An employee or immediate family member of an employee of Diamyd Medical AB.
- (US ONLY) For subjects aged 18 years and older, a body mass index (BMI) ≥25 kg/m2 or ≤18.5 kg/m2; for subject aged under 18 years BMI ≥85th percentile or ≤5th percentile for age and sex according to the US Centre for Disease Control and Prevention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diamyd
Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (rhGAD) on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)
|
Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®
Other Names:
Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).
Other Names:
|
Placebo Comparator: Placebo
Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (rhGAD) on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)
|
Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).
Other Names:
Placebo for Diamyd, Alhydrogel® only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in stimulated C-peptide during a MMTT
Time Frame: Baseline and 24 months
|
Change from baseline to Month 24 in C-peptide AUCmean 0-120 min during a 2 hour MMTT.
|
Baseline and 24 months
|
Change in hemoglobin A1c (HbA1c).
Time Frame: Baseline and 24 months
|
Mean difference in change from baseline to Month 24 in HbA1c (mmol/mol)
|
Baseline and 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) between baseline and Month 24.
Time Frame: Baseline and 24 months
|
Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) [evaluated from continuous glucose monitoring (CGM) data] between baseline and Month 24.
|
Baseline and 24 months
|
Proportion of patients with insulin dose-adjusted HbA1c ≤9 at Month 24.
Time Frame: 24 Months
|
Proportion of patients with insulin dose-adjusted HbA1c (IDDA1C) ≤9 at Month 24.
|
24 Months
|
Number of episodes per patient of severe hypoglycemia between baseline and Month 24.
Time Frame: Baseline and 24 months
|
Number of episodes per patient of severe hypoglycemia between baseline and Month 24.
|
Baseline and 24 months
|
Number of episodes per patient of diabetic ketoacidosis between baseline and Month 24.
Time Frame: Baseline and 24 months
|
Number of episodes per patient of diabetic ketoacidosis between baseline and Month 24
|
Baseline and 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Johnny Ludvigsson, Professor, Crown Princess Victoria Children´s Hospital and Linköping University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Diabetes
- Vitamin D
- Immune System Diseases
- Diabetes Mellitus
- Immunotherapy
- Autoimmune Diseases
- Type 1 Diabetes
- T1D
- Newly Diagnosed
- Metabolic Disease
- HLA
- Diamyd
- GAD65
- GAD
- rhGAD65
- Autoimmune Diabetes
- Diabetes Mellitus, Type 1
- GAD-alum
- Insulin Dependent Diabetes
- New onset
- residual beta cell function
- HLA DR3-DQ2
- residual c-peptide
- recent-onset T1D
- DIAGNODE-3
- Diamyd GAD
- Intralymphatic injections
- Diabetes immunotherapy
- Antigen-specific
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunologic Factors
- Gastrointestinal Agents
- Micronutrients
- Adjuvants, Immunologic
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Antacids
- Vitamin D
- Cholecalciferol
- Aluminum Hydroxide
Other Study ID Numbers
- DIAGNODE-3 (D/P3/21/7)
- 2021-002731-32 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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