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

PHASE3RecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

May 19, 2022

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Type 1 Diabetes Mellitus
Interventions
BIOLOGICAL

Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®

Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®

DIETARY_SUPPLEMENT

Colecalciferol 2000 IU

Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).

BIOLOGICAL

Placebo

Placebo for Diamyd, Alhydrogel® only

Trial Locations (60)

1036

RECRUITING

Óbudai Egészségügyi Centrum, Budapest

1089

RECRUITING

Heim Pál Országos Gyermekgyógyászati Intézet, Diabetológia, Budapest

1125

RECRUITING

Észak-Budai Szent János Centrumkórház, Kútvölgyi Kórház, Belgyógyászat, Budapest

4400

RECRUITING

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi, Oktatókórház, Jósa András Oktatókórház, Gyermekosztály, Nyíregyháza

9700

RECRUITING

Markusovszky Egyetemi Oktatókórház, Diabetológiai Szakrendelés, Szombathely

10016

RECRUITING

Hassenfeld Children's Hospital at NYU Langone Health, Pediatric Diabetes Center, New York

13419

RECRUITING

North-Estonian Regional Hospital, Tallinn

17007

RECRUITING

Hospital Universitari de Girona Dr. Josep Trueta, Girona

20502

RECRUITING

Skånes universitetssjukhus, Malmo

21287

RECRUITING

Johns Hopkins University, Baltimore

28007

RECRUITING

Hospital General Universitario Gregorio Marañón, Madrid

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

29010

RECRUITING

Hospital Regional Universitario de Málaga, Málaga

33136

RECRUITING

Diabetes Research Institute (DRI)-University of Miami Leonard M. Miller School of Medicine (UMMSM), Miami

35016

RECRUITING

Complejo Hospitalario Insular de Gran Canaria, Las Palmas

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

46014

RECRUITING

Hospital General Universitario de Valencia, Valencia

48903

RECRUITING

Hospital De Cruces, Barakaldo

50406

ACTIVE_NOT_RECRUITING

Tartu University Hospital, Tartu

51014

RECRUITING

Tartu University Hospital, Children's Clinic, Tartu

52242

RECRUITING

University of Iowa Hospital and Clinics, Iowa City

63110

RECRUITING

Washington University Diabetes Center at Barnes Jewish Hospital, St Louis

78237

RECRUITING

Diabetes & Glandular Disease Clinic, San Antonio

79124

RECRUITING

Amarillo Medical Specialists, Amarillo

80018

RECRUITING

Liina Viitas OÜ, Pärnu

80045

RECRUITING

University of Colorado Anschutz Medical Campus, Barbara Davis Center for Childhood Diabetes, Aurora

83404

RECRUITING

Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls

92123

RECRUITING

UCSD/ Rady Children's Hospital, San Diego

92663

RECRUITING

Mary and Dick Allen Diabetes Center at Hoag Hospital, Newport Beach

94304

TERMINATED

Stanford University School of Medicine Center for Academic Medicine, Palo Alto

02215

RECRUITING

Joslin Diabetes Center, Boston

586 01

RECRUITING

Nemocnice Jihlava, příspěvková organizace, Jihlava

140 21

RECRUITING

Institut klinické a experimentální medicíny, Prague

150 06

RECRUITING

Fakultní nemocnice v Motole, Prague

400 13

RECRUITING

Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z., Ústí nad Labem

131 87

RECRUITING

Diabetespraxis Dr. Braun, Berlin

441 37

RECRUITING

Diabetologische Schwerpunktpraxis Dres. Klaus, Dortmund

470 51

RECRUITING

DZDM - Diabeteszentrum Duisburg Mitte, Duisburg

353 92

RECRUITING

Justus-Liebig-Universität Gießen, Giessen

1105 AZ

RECRUITING

CTU Vasculaire Geneeskunde, Locatie Academic Medical Center (AMC), Amsterdam

3318 AT

RECRUITING

Albert Schweitzer Ziekenhuis, Dordrecht

7909 AA

RECRUITING

Bethesda Diabetes Research Center te Hoogeveen, Hoogeveen

2333 ZA

RECRUITING

Dept. of Nephrology / Dept. of Endocrinology, Leiden University Medical Center (LUMC), Leiden

6532 CL

ACTIVE_NOT_RECRUITING

Vivendia, Nijmegen

3011 TA

RECRUITING

Diabeter Nederland te Rotterdam, Rotterdam

15-274

RECRUITING

Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku, Klinika Pediatrii, Endokrynologii, Diabetologii z Pododdziałem Kardiologii, Bialystok

80-952

RECRUITING

Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Diabetologii i Endokrynologii, Gdansk

30-688

RECRUITING

SP ZOZ Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Chorób Metabolicznych i Diabetologii, Krakow

20-538

ACTIVE_NOT_RECRUITING

NZOZ Przychodnia Specjalistyczna Medica, Lublin

35-301

RECRUITING

Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie, II Klinika Pediatrii, Endokrynologii i Diabetologii Dziecięcej, Rzeszów

02-117

RECRUITING

Instytut Diabetologii Sp. z o.o, Warsaw

02-507

RECRUITING

Panstwowy Instytut Medyczny MSWiA Klinika Chorob Wewnetrznych, Endokrynologii i Diabetologii, Warsaw

04-730

RECRUITING

Instytut Pomnik - Centrum Zdrowia Dziecka (IPCZD) Oddział Diabetologii, Warsaw

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08036

RECRUITING

Hospital Clínic de Barcelona, Barcelona

08950

RECRUITING

Hospital de Sant Joan de Déu - Esplugues De Llobregat, Barcelona, Barcelona

102 35

ACTIVE_NOT_RECRUITING

Akademiskt Specialistcentrum, Centrum for Diabetes, Stockholm

901 85

RECRUITING

Barn-och Ungdomscentrum Västerbotten, Norrlands Universitetssjukhus, Umeå

581 85

RECRUITING

H.K.H Kronprinsessan Victorias Barn-och Ungdomssjukhus, Universitetssjukhuset i Linköping, Linköping

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Diamyd Medical AB

INDUSTRY