A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)
NCT ID: NCT00723411
Last Updated: 2011-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
334 participants
INTERVENTIONAL
2008-07-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on Days 90 and 270.
rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
B
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on Days 90 and 270.
rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
C
This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.
Placebo
Placebo injected subcutaneously at days 1, 30, 90 and 270
Interventions
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rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
Placebo
Placebo injected subcutaneously at days 1, 30, 90 and 270
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
* Fasting C-peptide level at time of screening above 0.1 nmol/L
* Elevated GAD65 antibodies (GADA) at time of screening
Exclusion Criteria
* A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
* Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
* Participation in other clinical trials with a new chemical entity within the previous 3 months
* Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
* Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
10 Years
20 Years
ALL
No
Sponsors
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Diamyd Therapeutics AB
INDUSTRY
Responsible Party
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Principal Investigators
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Johnny Ludvigsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala
Helsinki, , Finland
Kuopion yliopistollinen sairaala, Lasten klinikka
Kuopio, , Finland
Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka
Oulu, , Finland
Seinäjoen keskussairaala, Lastentautien poliklinikka
Seinäjoki, , Finland
Tampereen yliopistollinen sairaala, Lasten klinikka
Tampere, , Finland
Turun yliopistollinen keskussairaala, Lastentautien Klinikka
Turku, , Finland
Medecine B
Angers, , France
Centre Hospitalier Universitaire de Besançon
Besançon, , France
Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique
Bordeaux, , France
Hôpital Jeanne de Flandre Sce Pédiatrie
Lille, , France
CHU Timone Enfants, Service de pédiatrie multidisciplinaire
Marseille, , France
CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1
Montpellier, , France
C.H.U.Serv.Pediatrie
Nantes, , France
Hopital Robert Debré, Service d'Endocrinologie
Paris, , France
Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,
Paris, , France
CHU Rennes
Rennes, , France
Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique
Toulouse, , France
Charité Campus Virchow Childrens Hospital
Berlin, , Germany
DRK Kliniken Westend
Berlin, , Germany
Hannover Kinderkrankenhaus auf der Bult
Hanover, , Germany
Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig
Leipzig, , Germany
Klinik fȕr Kinder- und Jugendmedizin
Mȕnchen, , Germany
KHK Wilhelmstift
Rahlstedt, , Germany
Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen
Tȕbingen, , Germany
Unità Operativa di Pediatria, Policlinico
Bologna, , Italy
Struttura Complessa di Diabetologia, Ospedale S. Michele
Cagliari, , Italy
S.S. Annunziata, Clinica Pediatrica
Chieti, , Italy
Clinica Pediatrica, Università di Genova
Genova, , Italy
Reparto di Pediatria, Ospedale S. Raffaele
Milan, , Italy
Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco
Milan, , Italy
Azienda Ospedaliero, Universitaria di Parma, Pediatria
Parma, , Italy
Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia
Roma, , Italy
Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita
Torino, , Italy
Meander Medisch Centrum, Lokatie Elisabeth
Amersfoort, , Netherlands
Diabeter
Rotterdam, , Netherlands
Orbis Medisch Centrum
Sittard-Geleen, , Netherlands
Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis
The Hague, , Netherlands
University Medical Centre Ljubljana, Department of Pediatric Endocrinology
Ljubljana, , Slovenia
Hospital Materno-Infantil Vall Hebrón
Barcelona, , Spain
Hospital Materno-Infantil de Cruces
Cruces / Barakaldo, , Spain
Hospital Materno-Infantil Ramón y Cajal
Madrid, , Spain
Hospital Materno-Infantil La Paz
Madrid, , Spain
Hospital Materno-Infantil Carlos Haya
Málaga, , Spain
Hospital Materno-Infantil Vírgen del Camino
Pamplona, , Spain
Hospital Materno-Infantil Vírgen del Rocío
Seville, , Spain
Hospital Materno-Infantil Clínico de Valencia
Valencia, , Spain
Hospital Materno-Infantil Miguel Servet
Zaragoza, , Spain
Barn- och ungdomskliniken, Lasarettet
Borås, , Sweden
Barn- och ungdomskliniken, Länssjukhuset
Gävle, , Sweden
Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården
Gothenburg, , Sweden
Barn- och ungdomskliniken, Länssjukhuset
Halmstad, , Sweden
Barn- och ungdomsmedicin, Lasarettet
Helsingborg, , Sweden
Barnkliniken, Hudiksvalls Sjukhus
Hudiksvall, , Sweden
Barn- och ungdomskliniken, Länssjukhuset Ryhov
Jönköping, , Sweden
Barn- och ungdomskliniken, Lasarettet
Kalmar, , Sweden
Barn- och ungdomskliniken, Centralsjukhuset
Karlstad, , Sweden
Barn och ungdomsmedicinska kliniken, Centralsjukhuset
Kristianstad, , Sweden
Barn- och ungdomskliniken, Universitetssjukhuset
Linköping, , Sweden
Barn- och ungdomskliniken, Universitetssjukhuset
Lund, , Sweden
Barn- och ungdomscentrum, Universitetssjukhuset MAS
Malmo, , Sweden
Barn- och ungdomskliniken, Vrinnevi sjukhus
Norrköping, , Sweden
Barn- och ungdomskliniken, Universitetssjukhuset
Örebro, , Sweden
Sachsska Barnsjukhuset, Södersjukhuset
Stockholm, , Sweden
Barn- och ungdomskliniken, NU-sjukvården/NÄL
Trollhättan, , Sweden
Barn- och ungdomskliniken, Uddevalla Sjukhus
Uddevalla, , Sweden
Barn- och ungdomskliniken, Centrallasarettet
Vaxjo, , Sweden
Barn- och ungdomskliniken, Centrallasarettet
Västerås, , Sweden
Maternal & Child Health Sciences, University of Dundee
Dundee, , United Kingdom
Children's Admin Centre
Leicester, , United Kingdom
Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry
London, , United Kingdom
Countries
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References
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Tavira B, Cheramy M, Axelsson S, Akerman L, Ludvigsson J, Casas R. Effect of simultaneous vaccination with H1N1 and GAD-alum on GAD65-induced immune response. Diabetologia. 2017 Jul;60(7):1276-1283. doi: 10.1007/s00125-017-4263-x. Epub 2017 Mar 29.
Ludvigsson J, Cheramy M, Axelsson S, Pihl M, Akerman L, Casas R; Clinical GAD-Study Group in Sweden. GAD-treatment of children and adolescents with recent-onset type 1 diabetes preserves residual insulin secretion after 30 months. Diabetes Metab Res Rev. 2014 Jul;30(5):405-14. doi: 10.1002/dmrr.2503.
Ludvigsson J, Krisky D, Casas R, Battelino T, Castano L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Aman J, Kardell G, Neiderud Helsingborg J, Lundstrom G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanas R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NO, Akesson CG, Keskinen P, Veijola R, Talvitie T, Raile K, Kapellen T, Burger W, Neu A, Engelsberger I, Heidtmann B, Bechtold S, Leslie D, Chiarelli F, Cicognani A, Chiumello G, Cerutti F, Zuccotti GV, Gomez Gila A, Rica I, Barrio R, Clemente M, Lopez Garcia MJ, Rodriguez M, Gonzalez I, Lopez JP, Oyarzabal M, Reeser HM, Nuboer R, Stouthart P, Bratina N, Bratanic N, de Kerdanet M, Weill J, Ser N, Barat P, Bertrand AM, Carel JC, Reynaud R, Coutant R, Baron S. GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. N Engl J Med. 2012 Feb 2;366(5):433-42. doi: 10.1056/NEJMoa1107096.
Other Identifiers
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D/P3/07/4
Identifier Type: -
Identifier Source: org_study_id