Clinical trial NCT00723411: A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)
Official title: A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (EU)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: Diabetes
Juvenile Diabetes
Diabetes type 1
Autoimmune Diabetes
Insulin dependent Diabetes
Type 1 diabetes
Type 1 diabetes mellitus
Diamyd
rhGAD65
GAD
GAD-alum
Lead sponsor: Diamyd Therapeutics AB
Sponsor class: INDUSTRY
First posted: 2008-07-28
Enrollment: 334
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.


Eligibility criteria: Main Inclusion Criteria:

* Male and female patients between 10 and 20 years of age
* 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

Main Exclusion Criteria:

* Treatment with immunosuppressants or any anti-diabetic medications other than insulin
* 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

Primary outcomes:
measure: Meal stimulated C-peptide (area under the curve)
timeFrame: 15 months
Secondary outcomes:
measure: HbA1c
timeFrame: 15 months
measure: Insulin Dose
timeFrame: 15 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala
city: Kuopio
country: Finland
facility: Kuopion yliopistollinen sairaala, Lasten klinikka
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka
city: Seinäjoki
country: Finland
facility: Seinäjoen keskussairaala, Lastentautien poliklinikka
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala, Lasten klinikka
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala, Lastentautien Klinikka
city: Angers
country: France
facility: Medecine B
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Bordeaux
country: France
facility: Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique
city: Lille
country: France
facility: Hôpital Jeanne de Flandre Sce Pédiatrie
city: Marseilles
country: France
facility: CHU Timone Enfants, Service de pédiatrie multidisciplinaire
city: Montpellier
country: France
facility: CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1
city: Nantes
country: France
facility: C.H.U.Serv.Pediatrie
city: Paris
country: France
facility: Hopital Robert Debré, Service d'Endocrinologie
city: Paris
country: France
facility: Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,
city: Rennes
country: France
facility: CHU Rennes
city: Toulouse
country: France
facility: Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique
city: Berlin
country: Germany
facility: Charité Campus Virchow Childrens Hospital
city: Berlin
country: Germany
facility: DRK Kliniken Westend
city: Hamburg-Rahlstedt
country: Germany
facility: KHK Wilhelmstift
city: Hannover
country: Germany
facility: Hannover Kinderkrankenhaus auf der Bult
city: Leipzig
country: Germany
facility: Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig
city: Mȕnchen
country: Germany
facility: Klinik fȕr Kinder- und Jugendmedizin
city: Tȕbingen
country: Germany
facility: Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen
city: Bologna
country: Italy
facility: Unità Operativa di Pediatria, Policlinico
city: Cagliari
country: Italy
facility: Struttura Complessa di Diabetologia, Ospedale S. Michele
city: Chieti
country: Italy
facility: S.S. Annunziata, Clinica Pediatrica
city: Genova
country: Italy
facility: Clinica Pediatrica, Università di Genova
city: Milano
country: Italy
facility: Reparto di Pediatria, Ospedale S. Raffaele
city: Milano
country: Italy
facility: Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco
city: Parma
country: Italy
facility: Azienda Ospedaliero, Universitaria di Parma, Pediatria
city: Roma
country: Italy
facility: Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia
city: Torino
country: Italy
facility: Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum, Lokatie Elisabeth
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis
city: Rotterdam
country: Netherlands
facility: Diabeter
city: Sittard-Geleen
country: Netherlands
facility: Orbis Medisch Centrum
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana, Department of Pediatric Endocrinology
city: Barcelona
country: Spain
facility: Hospital Materno-Infantil Vall Hebrón
city: Cruces / Barakaldo
country: Spain
facility: Hospital Materno-Infantil de Cruces
city: Madrid
country: Spain
facility: Hospital Materno-Infantil Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Materno-Infantil La Paz
city: Málaga
country: Spain
facility: Hospital Materno-Infantil Carlos Haya
city: Pamplona
country: Spain
facility: Hospital Materno-Infantil Vírgen del Camino
city: Sevilla
country: Spain
facility: Hospital Materno-Infantil Vírgen del Rocío
city: Valencia
country: Spain
facility: Hospital Materno-Infantil Clínico de Valencia
city: Zaragoza
country: Spain
facility: Hospital Materno-Infantil Miguel Servet
city: Borås
country: Sweden
facility: Barn- och ungdomskliniken, Lasarettet
city: Gävle
country: Sweden
facility: Barn- och ungdomskliniken, Länssjukhuset
city: Göteborg
country: Sweden
facility: Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården
city: Halmstad
country: Sweden
facility: Barn- och ungdomskliniken, Länssjukhuset
city: Helsingborg
country: Sweden
facility: Barn- och ungdomsmedicin, Lasarettet
city: Hudiksvall
country: Sweden
facility: Barnkliniken, Hudiksvalls Sjukhus
city: Jönköping
country: Sweden
facility: Barn- och ungdomskliniken, Länssjukhuset Ryhov
city: Kalmar
country: Sweden
facility: Barn- och ungdomskliniken, Lasarettet
city: Karlstad
country: Sweden
facility: Barn- och ungdomskliniken, Centralsjukhuset
city: Kristianstad
country: Sweden
facility: Barn och ungdomsmedicinska kliniken, Centralsjukhuset
city: Linköping
country: Sweden
facility: Barn- och ungdomskliniken, Universitetssjukhuset
city: Lund
country: Sweden
facility: Barn- och ungdomskliniken, Universitetssjukhuset
city: Malmö
country: Sweden
facility: Barn- och ungdomscentrum, Universitetssjukhuset MAS
city: Norrköping
country: Sweden
facility: Barn- och ungdomskliniken, Vrinnevi sjukhus
city: Stockholm
country: Sweden
facility: Sachsska Barnsjukhuset, Södersjukhuset
city: Trollhättan
country: Sweden
facility: Barn- och ungdomskliniken, NU-sjukvården/NÄL
city: Uddevalla
country: Sweden
facility: Barn- och ungdomskliniken, Uddevalla Sjukhus
city: Västerås
country: Sweden
facility: Barn- och ungdomskliniken, Centrallasarettet
city: Växjö
country: Sweden
facility: Barn- och ungdomskliniken, Centrallasarettet
city: Örebro
country: Sweden
facility: Barn- och ungdomskliniken, Universitetssjukhuset
city: Dundee
country: United Kingdom
facility: Maternal & Child Health Sciences, University of Dundee
city: Leicester
country: United Kingdom
facility: Children's Admin Centre
city: London
country: United Kingdom
facility: Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry
Study officials:
affiliation: Linkoeping University
name: Johnny Ludvigsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.