A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)
- Registration Number
- NCT00723411
- Lead Sponsor
- Diamyd Therapeutics AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 334
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C Placebo This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270. A rhGAD65 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. B rhGAD65 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.
- Primary Outcome Measures
Name Time Method Meal stimulated C-peptide (area under the curve) 15 months
- Secondary Outcome Measures
Name Time Method HbA1c 15 months Insulin Dose 15 months
Trial Locations
- Locations (65)
Seinäjoen keskussairaala, Lastentautien poliklinikka
🇫🇮Seinäjoki, Finland
Orbis Medisch Centrum
🇳🇱Sittard-Geleen, Netherlands
Turun yliopistollinen keskussairaala, Lastentautien Klinikka
🇫🇮Turku, Finland
Kuopion yliopistollinen sairaala, Lasten klinikka
🇫🇮Kuopio, Finland
Diabeter
🇳🇱Rotterdam, Netherlands
Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala
🇫🇮Helsinki, Finland
University Medical Centre Ljubljana, Department of Pediatric Endocrinology
🇸🇮Ljubljana, Slovenia
Meander Medisch Centrum, Lokatie Elisabeth
🇳🇱Amersfoort, Netherlands
CHU Timone Enfants, Service de pédiatrie multidisciplinaire
🇫🇷Marseilles, France
Hôpital Jeanne de Flandre Sce Pédiatrie
🇫🇷Lille, France
C.H.U.Serv.Pediatrie
🇫🇷Nantes, France
Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,
🇫🇷Paris, France
CHU Rennes
🇫🇷Rennes, France
Tampereen yliopistollinen sairaala, Lasten klinikka
🇫🇮Tampere, Finland
Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique
🇫🇷Bordeaux, France
CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1
🇫🇷Montpellier, France
Hannover Kinderkrankenhaus auf der Bult
🇩🇪Hannover, Germany
KHK Wilhelmstift
🇩🇪Hamburg-Rahlstedt, Germany
Hopital Robert Debré, Service d'Endocrinologie
🇫🇷Paris, France
Klinik fȕr Kinder- und Jugendmedizin
🇩🇪Mȕnchen, Germany
DRK Kliniken Westend
🇩🇪Berlin, Germany
Charité Campus Virchow Childrens Hospital
🇩🇪Berlin, Germany
Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig
🇩🇪Leipzig, Germany
Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique
🇫🇷Toulouse, France
Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen
🇩🇪Tȕbingen, Germany
Unità Operativa di Pediatria, Policlinico
🇮🇹Bologna, Italy
Reparto di Pediatria, Ospedale S. Raffaele
🇮🇹Milano, Italy
Struttura Complessa di Diabetologia, Ospedale S. Michele
🇮🇹Cagliari, Italy
S.S. Annunziata, Clinica Pediatrica
🇮🇹Chieti, Italy
Clinica Pediatrica, Università di Genova
🇮🇹Genova, Italy
Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis
🇳🇱Den Haag, Netherlands
Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita
🇮🇹Torino, Italy
Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco
🇮🇹Milano, Italy
Azienda Ospedaliero, Universitaria di Parma, Pediatria
🇮🇹Parma, Italy
Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia
🇮🇹Roma, Italy
Hospital Materno-Infantil de Cruces
🇪🇸Cruces / Barakaldo, Spain
Hospital Materno-Infantil Vall Hebrón
🇪🇸Barcelona, Spain
Hospital Materno-Infantil Ramón y Cajal
🇪🇸Madrid, Spain
Barn- och ungdomskliniken, Länssjukhuset Ryhov
🇸🇪Jönköping, Sweden
Barn- och ungdomskliniken, Centralsjukhuset
🇸🇪Karlstad, Sweden
Barn- och ungdomskliniken, Universitetssjukhuset
🇸🇪Örebro, Sweden
Hospital Materno-Infantil La Paz
🇪🇸Madrid, Spain
Hospital Materno-Infantil Vírgen del Rocío
🇪🇸Sevilla, Spain
Hospital Materno-Infantil Vírgen del Camino
🇪🇸Pamplona, Spain
Hospital Materno-Infantil Carlos Haya
🇪🇸Málaga, Spain
Barnkliniken, Hudiksvalls Sjukhus
🇸🇪Hudiksvall, Sweden
Barn och ungdomsmedicinska kliniken, Centralsjukhuset
🇸🇪Kristianstad, Sweden
Barn- och ungdomscentrum, Universitetssjukhuset MAS
🇸🇪Malmö, Sweden
Hospital Materno-Infantil Clínico de Valencia
🇪🇸Valencia, Spain
Hospital Materno-Infantil Miguel Servet
🇪🇸Zaragoza, Spain
Barn- och ungdomskliniken, Lasarettet
🇸🇪Kalmar, Sweden
Barn- och ungdomskliniken, Länssjukhuset
🇸🇪Halmstad, Sweden
Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården
🇸🇪Göteborg, Sweden
Barn- och ungdomsmedicin, Lasarettet
🇸🇪Helsingborg, Sweden
Barn- och ungdomskliniken, Vrinnevi sjukhus
🇸🇪Norrköping, Sweden
Sachsska Barnsjukhuset, Södersjukhuset
🇸🇪Stockholm, Sweden
Barn- och ungdomskliniken, NU-sjukvården/NÄL
🇸🇪Trollhättan, Sweden
Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry
🇬🇧London, United Kingdom
Children's Admin Centre
🇬🇧Leicester, United Kingdom
Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka
🇫🇮Oulu, Finland
Medecine B
🇫🇷Angers, France
Centre Hospitalier Universitaire de Besançon
🇫🇷Besançon, France
Barn- och ungdomskliniken, Uddevalla Sjukhus
🇸🇪Uddevalla, Sweden
Maternal & Child Health Sciences, University of Dundee
🇬🇧Dundee, United Kingdom
Barn- och ungdomskliniken, Centrallasarettet
🇸🇪Växjö, Sweden