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

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ClinicalTrials.gov Identifier: NCT00723411
Recruitment Status : Terminated (The primary endpoint at 15 months was not met.)
First Posted : July 28, 2008
Last Update Posted : October 10, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: rhGAD65 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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.
Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
Other Names:
  • Diamyd
  • GAD65
  • GAD-Alum
  • GAD
Active Comparator: 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.
Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
Other Names:
  • Diamyd
  • GAD
  • GAD65
  • GAD-Alum
Placebo Comparator: C
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



Primary Outcome Measures :
  1. Meal stimulated C-peptide (area under the curve) [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 15 months ]
  2. Insulin Dose [ Time Frame: 15 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723411


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Locations
Finland
Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala
Helsinki, Finland, FI-00029
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
Tampereen yliopistollinen sairaala, Lasten klinikka
Tampere, Finland, FI-33521
Turun yliopistollinen keskussairaala, Lastentautien Klinikka
Turku, Finland, FI-20521
France
Medecine B
Angers, France, 49033
Centre Hospitalier Universitaire de Besançon
Besançon, France, 25030
Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique
Bordeaux, France, 33076
Hôpital Jeanne de Flandre Sce Pédiatrie
Lille, France, 59037
CHU Timone Enfants, Service de pédiatrie multidisciplinaire
Marseilles, France, 13385
CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1
Montpellier, France, 34295
C.H.U.Serv.Pediatrie
Nantes, France, 44093
Hopital Robert Debré, Service d'Endocrinologie
Paris, France, 3319
Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,
Paris, France, 75743
CHU Rennes
Rennes, France, 35000
Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique
Toulouse, France, 70034
Germany
Charité Campus Virchow Childrens Hospital
Berlin, Germany, 13353
DRK Kliniken Westend
Berlin, Germany, 14050
KHK Wilhelmstift
Hamburg-Rahlstedt, Germany, 22149
Hannover Kinderkrankenhaus auf der Bult
Hannover, Germany, 30173
Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig
Leipzig, Germany, 04103
Klinik fȕr Kinder- und Jugendmedizin
Mȕnchen, Germany, 80804
Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen
Tȕbingen, Germany, 72076
Italy
Unità Operativa di Pediatria, Policlinico
Bologna, Italy, 40138
Struttura Complessa di Diabetologia, Ospedale S. Michele
Cagliari, Italy, 09134
S.S. Annunziata, Clinica Pediatrica
Chieti, Italy, 66013
Clinica Pediatrica, Università di Genova
Genova, Italy, 16147
Reparto di Pediatria, Ospedale S. Raffaele
Milano, Italy, 20132
Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco
Milano, Italy, 20157
Azienda Ospedaliero, Universitaria di Parma, Pediatria
Parma, Italy, 43100
Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia
Roma, Italy, 00128
Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita
Torino, Italy, 10126
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 Vall Hebrón
Barcelona, Spain, 08035
Hospital Materno-Infantil de Cruces
Cruces / Barakaldo, Spain, 48903
Hospital Materno-Infantil Ramón y Cajal
Madrid, Spain, 28034
Hospital Materno-Infantil La Paz
Madrid, Spain, 28046
Hospital Materno-Infantil Carlos Haya
Málaga, Spain, 29011
Hospital Materno-Infantil Vírgen del Camino
Pamplona, Spain, 31008
Hospital Materno-Infantil Vírgen del Rocío
Sevilla, Spain, 41013
Hospital Materno-Infantil Clínico de Valencia
Valencia, Spain, 46010
Hospital Materno-Infantil Miguel Servet
Zaragoza, Spain, 50009
Sweden
Barn- och ungdomskliniken, Lasarettet
Borås, Sweden, SE-501 82
Barn- och ungdomskliniken, Länssjukhuset
Gävle, Sweden, SE-801 87
Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården
Göteborg, Sweden, SE-416 85
Barn- och ungdomskliniken, Länssjukhuset
Halmstad, Sweden, SE-301 85
Barn- och ungdomsmedicin, Lasarettet
Helsingborg, Sweden, SE-251 87
Barnkliniken, Hudiksvalls Sjukhus
Hudiksvall, Sweden, SE-824 81
Barn- och ungdomskliniken, Länssjukhuset Ryhov
Jönköping, Sweden, SE-551 85
Barn- och ungdomskliniken, Lasarettet
Kalmar, Sweden, SE-391 85
Barn- och ungdomskliniken, Centralsjukhuset
Karlstad, Sweden, SE-651 85
Barn och ungdomsmedicinska kliniken, Centralsjukhuset
Kristianstad, Sweden, SE-291 33
Barn- och ungdomskliniken, Universitetssjukhuset
Linköping, Sweden, SE-581 85
Barn- och ungdomskliniken, Universitetssjukhuset
Lund, Sweden, SE-221 85
Barn- och ungdomscentrum, Universitetssjukhuset MAS
Malmö, Sweden, SE-205 02
Barn- och ungdomskliniken, Vrinnevi sjukhus
Norrköping, Sweden, SE-601 83
Sachsska Barnsjukhuset, Södersjukhuset
Stockholm, Sweden, SE-118 83
Barn- och ungdomskliniken, NU-sjukvården/NÄL
Trollhättan, Sweden, SE-461 85
Barn- och ungdomskliniken, Uddevalla Sjukhus
Uddevalla, Sweden, SE-451 80
Barn- och ungdomskliniken, Centrallasarettet
Västerås, Sweden, SE-721 89
Barn- och ungdomskliniken, Centrallasarettet
Växjö, Sweden, SE-351 85
Barn- och ungdomskliniken, Universitetssjukhuset
Örebro, Sweden, SE-701 85
United Kingdom
Maternal & Child Health Sciences, University of Dundee
Dundee, United Kingdom, DD1 9SY
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
Sponsors and Collaborators
Diamyd Therapeutics AB
Investigators
Principal Investigator: Johnny Ludvigsson, MD, PhD Linköping University, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Ludvigsson J, Krisky D, Casas R, Battelino T, Castaño L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Åman J, Kärdell G, Neiderud Helsingborg J, Lundström G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanås R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NÖ, Åkesson 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, López 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.

Responsible Party: Diamyd Therapeutics AB
ClinicalTrials.gov Identifier: NCT00723411     History of Changes
Other Study ID Numbers: D/P3/07/4
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: October 10, 2011
Last Verified: October 2011

Keywords provided by Diamyd Therapeutics AB:
Diamyd
Diabetes
Juvenile Diabetes
Diabetes type 1
Autoimmune Diabetes
Insulin dependent Diabetes
Type 1 diabetes
Type 1 diabetes mellitus
rhGAD65
GAD
GAD-alum

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases