A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU) - Full Text View

Sponsor:	Diamyd Therapeutics AB
Information provided by:	Diamyd Therapeutics AB
ClinicalTrials.gov Identifier:	NCT00723411

Purpose

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.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus	Drug: rhGAD65 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Aluminum sulfate Alum, Potassium

U.S. FDA Resources

Further study details as provided by Diamyd Therapeutics AB:

Primary Outcome Measures:

Meal stimulated C-peptide (area under the curve) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HbA1c [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Insulin Dose [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	July 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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.	Drug: rhGAD65 Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
B: Active Comparator 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.	Drug: rhGAD65 Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
C: Placebo Comparator This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.	Drug: Placebo Placebo injected subcutaneously at days 1, 30, 90 and 270

Eligibility

Ages Eligible for Study:	10 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723411

Hide Study Locations

Locations

Finland
Kuopion yliopistollinen sairaala, Lasten klinikka
Kuopio, Finland, FI-70211
Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka
Oulu, Finland, FI-90029
Seinäjoen keskussairaala, Lastentautien poliklinikka
Seinäjoki, Finland, FI-60220
Turun yliopistollinen keskussairaala, Lastentautien Klinikka
Turku, Finland, FI-20521
Tampereen yliopistollinen sairaala, Lasten klinikka
Tampere, Finland, FI-33521
Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala
Helsinki, Finland, FI-00029
France
Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,
Paris, France, 75743
CHU Rennes
Rennes, France, 35000
C.H.U.Serv.Pediatrie
Nantes, France, 44093
Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique
Toulouse, France, 70034
CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1
Montpellier, France, 34295
Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique
Bordeaux, France, 33076
Centre Hospitalier Universitaire de Besançon
Besançon, France, 25030
Hopital Robert Debré, Service d'Endocrinologie
Paris, France, 3319
CHU Timone Enfants, Service de pédiatrie multidisciplinaire
Marseilles, France, 13385
MEDECINE B
Angers, France, 49033
Hôpital Jeanne de Flandre Sce Pédiatrie
Lille, France, 59037
Germany
Hannover Kinderkrankenhaus auf der Bult
Hannover, Germany, 30173
Charité Campus Virchow Childrens Hospital
Berlin, Germany, 13353
Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig
Leipzig, Germany, 04103
DRK Kliniken Westend
Berlin, Germany, 14050
Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen
Tȕbingen, Germany, 72076
Klinik fȕr Kinder- und Jugendmedizin
Mȕnchen, Germany, 80804
KHK Wilhelmstift
Hamburg-Rahlstedt, Germany, 22149
Italy
Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia
Roma, Italy, 00128
S.S. Annunziata, Clinica Pediatrica
Chieti, Italy, 66013
Unità Operativa di Pediatria, Policlinico
Bologna, Italy, 40138
Azienda Ospedaliero, Universitaria di Parma, Pediatria
Parma, Italy, 43100
Clinica Pediatrica, Università di Genova
Genova, Italy, 16147
Reparto di Pediatria, Ospedale S. Raffaele
Milano, Italy, 20132
Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita
Torino, Italy, 10126
Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco
Milano, Italy, 20157
Struttura Complessa di Diabetologia, Ospedale S. Michele
Cagliari, Italy, 09134
Netherlands
Meander Medisch Centrum, Lokatie Elisabeth
Amersfoort, Netherlands, 3816 CP
Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis
Den Haag, Netherlands, 2566 MJ
Diabeter
Rotterdam, Netherlands, 3011 TG
Orbis Medisch Centrum
Sittard-Geleen, Netherlands, 6162
Slovenia
University Medical Centre Ljubljana, Department of Pediatric Endocrinology
Ljubljana, Slovenia, 1525
Spain
Hospital Materno-Infantil Miguel Servet
Zaragoza, Spain, 50009
Hospital Materno-Infantil Vall Hebrón
Barcelona, Spain, 08035
Hospital Materno-Infantil Ramón y Cajal
Madrid, Spain, 28034
Hospital Materno-Infantil Carlos Haya
Málaga, Spain, 29011
Hospital Materno-Infantil de Cruces
Cruces / Barakaldo, Spain, 48903
Hospital Materno-Infantil La Paz
Madrid, Spain, 28046
Hospital Materno-Infantil Clínico de Valencia
Valencia, Spain, 46010
Hospital Materno-Infantil Vírgen del Rocío
Sevilla, Spain, 41013
Hospital Materno-Infantil Vírgen del Camino
Pamplona, Spain, 31008
Sweden
Barn- och ungdomskliniken, Lasarettet
Borås, Sweden, SE-501 82
Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården
Göteborg, Sweden, SE-416 85
Barn- och ungdomscentrum, Universitetssjukhuset MAS
Malmö, Sweden, SE-205 02
Barn- och ungdomskliniken, Länssjukhuset Ryhov
Jönköping, Sweden, SE-551 85
Barn- och ungdomskliniken, Universitetssjukhuset
Linköping, Sweden, SE-581 85
Barn- och ungdomskliniken, Länssjukhuset
Halmstad, Sweden, SE-301 85
Barn- och ungdomskliniken, Universitetssjukhuset
Örebro, Sweden, SE-701 85
Barn- och ungdomskliniken, Länssjukhuset
Gävle, Sweden, SE-801 87
Barn- och ungdomsmedicin, Lasarettet
Helsingborg, Sweden, SE-251 87
Barn- och ungdomskliniken, Lasarettet
Kalmar, Sweden, SE-391 85
Barn- och ungdomskliniken, Centralsjukhuset
Karlstad, Sweden, SE-651 85
Barn- och ungdomskliniken, Centrallasarettet
Västerås, Sweden, SE-721 89
Barn- och ungdomskliniken, Vrinnevi sjukhus
Norrköping, Sweden, SE-601 83
Barn- och ungdomskliniken, NU-sjukvården/NÄL
Trollhättan, Sweden, SE-461 85
Barn- och ungdomskliniken, Universitetssjukhuset
Lund, Sweden, SE-221 85
Barn- och ungdomskliniken, Centrallasarettet
Växjö, Sweden, SE-351 85
Barn- och ungdomskliniken, Uddevalla Sjukhus
Uddevalla, Sweden, SE-451 80
Barn och ungdomsmedicinska kliniken, Centralsjukhuset
Kristianstad, Sweden, SE-291 33
Sachsska Barnsjukhuset, Södersjukhuset
Stockholm, Sweden, SE-118 83
Barnkliniken, Hudiksvalls Sjukhus
Hudiksvall, Sweden, SE-824 81
United Kingdom
Children's Admin Centre
Leicester, United Kingdom, LE1 5WW
Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry
London, United Kingdom, E1 2AT
Maternal & Child Health Sciences, University of Dundee
Dundee, United Kingdom, DD1 9SY

Sponsors and Collaborators

Diamyd Therapeutics AB

Investigators

Principal Investigator:

Johnny Ludvigsson, MD, PhD

Linköping University, Sweden

More Information

No publications provided

Responsible Party:	Diamyd Therapeutics AB ( Managing Director )
Study ID Numbers:	D/P3/07/4
Study First Received:	July 24, 2008
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00723411 History of Changes
Health Authority:	Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board; Finland: Finnish Medicines Agency; Finland: Ethics Committee; Slovenia: Agency for Medicinal Products - Ministry of Health; Slovenia: Ethics Committee; Spain: Spanish Agency of Medicines; Spain: Comité Ético de Investigación Clínica; Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Italy: The Italian Medicines Agency; Italy: Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission; France: Agence francaise de sécurité sanitaire des produits de santé, (afssaps); France: Institutional Ethical Committee

Keywords provided by Diamyd Therapeutics AB:

Diabetes
Juvenile Diabetes
Diabetes type 1
Autoimmune Diabetes
Insulin dependent Diabetes
Type 1 diabetes

Type 1 diabetes mellitus
Diamyd
rhGAD65
GAD
GAD-alum

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009