A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, Diamyd, rhGAD65, GAD, GAD-alum
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
Sites / Locations
- Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala
- Kuopion yliopistollinen sairaala, Lasten klinikka
- Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka
- Seinäjoen keskussairaala, Lastentautien poliklinikka
- Tampereen yliopistollinen sairaala, Lasten klinikka
- Turun yliopistollinen keskussairaala, Lastentautien Klinikka
- Medecine B
- Centre Hospitalier Universitaire de Besançon
- Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique
- Hôpital Jeanne de Flandre Sce Pédiatrie
- CHU Timone Enfants, Service de pédiatrie multidisciplinaire
- CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1
- C.H.U.Serv.Pediatrie
- Hopital Robert Debré, Service d'Endocrinologie
- Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,
- CHU Rennes
- Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique
- Charité Campus Virchow Childrens Hospital
- DRK Kliniken Westend
- KHK Wilhelmstift
- Hannover Kinderkrankenhaus auf der Bult
- Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig
- Klinik fȕr Kinder- und Jugendmedizin
- Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen
- Unità Operativa di Pediatria, Policlinico
- Struttura Complessa di Diabetologia, Ospedale S. Michele
- S.S. Annunziata, Clinica Pediatrica
- Clinica Pediatrica, Università di Genova
- Reparto di Pediatria, Ospedale S. Raffaele
- Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco
- Azienda Ospedaliero, Universitaria di Parma, Pediatria
- Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia
- Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita
- Meander Medisch Centrum, Lokatie Elisabeth
- Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis
- Diabeter
- Orbis Medisch Centrum
- University Medical Centre Ljubljana, Department of Pediatric Endocrinology
- Hospital Materno-Infantil Vall Hebrón
- Hospital Materno-Infantil de Cruces
- Hospital Materno-Infantil Ramón y Cajal
- Hospital Materno-Infantil La Paz
- Hospital Materno-Infantil Carlos Haya
- Hospital Materno-Infantil Vírgen del Camino
- Hospital Materno-Infantil Vírgen del Rocío
- Hospital Materno-Infantil Clínico de Valencia
- Hospital Materno-Infantil Miguel Servet
- Barn- och ungdomskliniken, Lasarettet
- Barn- och ungdomskliniken, Länssjukhuset
- Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården
- Barn- och ungdomskliniken, Länssjukhuset
- Barn- och ungdomsmedicin, Lasarettet
- Barnkliniken, Hudiksvalls Sjukhus
- Barn- och ungdomskliniken, Länssjukhuset Ryhov
- Barn- och ungdomskliniken, Lasarettet
- Barn- och ungdomskliniken, Centralsjukhuset
- Barn och ungdomsmedicinska kliniken, Centralsjukhuset
- Barn- och ungdomskliniken, Universitetssjukhuset
- Barn- och ungdomskliniken, Universitetssjukhuset
- Barn- och ungdomscentrum, Universitetssjukhuset MAS
- Barn- och ungdomskliniken, Vrinnevi sjukhus
- Sachsska Barnsjukhuset, Södersjukhuset
- Barn- och ungdomskliniken, NU-sjukvården/NÄL
- Barn- och ungdomskliniken, Uddevalla Sjukhus
- Barn- och ungdomskliniken, Centrallasarettet
- Barn- och ungdomskliniken, Centrallasarettet
- Barn- och ungdomskliniken, Universitetssjukhuset
- Maternal & Child Health Sciences, University of Dundee
- Children's Admin Centre
- Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
A
B
C
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.
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.
This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.