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

NCT00723411 | Terminated Phase 3 DMC

• 1 other identifier: D/P3/07/4
• Study Type: interventional
• Target: 334
• Locations: 9 countries
• Sites: 70

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.

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

Outcome Measures

Primary Outcomes (1)

• Meal stimulated C-peptide (area under the curve)

  15 months

Secondary Outcomes (2)

• HbA1c

  15 months

• Insulin Dose

  15 months

Study Arms (3)

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

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

C

PLACEBO COMPARATOR

This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.

Drug: Placebo

Interventions

rhGAD65 DRUG

Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.

Also known as: Diamyd, GAD65, GAD-Alum, GAD

A

Placebo DRUG

Placebo injected subcutaneously at days 1, 30, 90 and 270

C

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diamyd Therapeutics AB: lead

Study Sites (70)

Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala

Helsinki, FI-00029, Finland

Location

Kuopion yliopistollinen sairaala, Lasten klinikka

Kuopio, FI-70211, Finland

Location

Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka

Oulu, FI-90029, Finland

Location

Seinäjoen keskussairaala, Lastentautien poliklinikka

Seinäjoki, FI-60220, Finland

Location

Tampereen yliopistollinen sairaala, Lasten klinikka

Tampere, FI-33521, Finland

Location

Turun yliopistollinen keskussairaala, Lastentautien Klinikka

Turku, FI-20521, Finland

Location

Medecine B

Angers, 49033, France

Location

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

Location

Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique

Bordeaux, 33076, France

Location

Hôpital Jeanne de Flandre Sce Pédiatrie

Lille, 59037, France

Location

CHU Timone Enfants, Service de pédiatrie multidisciplinaire

Marseille, 13385, France

Location

CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1

Montpellier, 34295, France

Location

C.H.U.Serv.Pediatrie

Nantes, 44093, France

Location

Hopital Robert Debré, Service d'Endocrinologie

Paris, 3319, France

Location

Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,

Paris, 75743, France

Location

CHU Rennes

Rennes, 35000, France

Location

Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique

Toulouse, 70034, France

Location

Charité Campus Virchow Childrens Hospital

Berlin, 13353, Germany

Location

DRK Kliniken Westend

Berlin, 14050, Germany

Location

Hannover Kinderkrankenhaus auf der Bult

Hanover, 30173, Germany

Location

Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig

Leipzig, 04103, Germany

Location

Klinik fȕr Kinder- und Jugendmedizin

Mȕnchen, 80804, Germany

Location

KHK Wilhelmstift

Rahlstedt, 22149, Germany

Location

Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen

Tȕbingen, 72076, Germany

Location

Unità Operativa di Pediatria, Policlinico

Bologna, 40138, Italy

Location

Struttura Complessa di Diabetologia, Ospedale S. Michele

Cagliari, 09134, Italy

Location

S.S. Annunziata, Clinica Pediatrica

Chieti, 66013, Italy

Location

Clinica Pediatrica, Università di Genova

Genova, 16147, Italy

Location

Reparto di Pediatria, Ospedale S. Raffaele

Milan, 20132, Italy

Location

Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Azienda Ospedaliero, Universitaria di Parma, Pediatria

Parma, 43100, Italy

Location

Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia

Roma, 00128, Italy

Location

Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita

Torino, 10126, Italy

Location

Meander Medisch Centrum, Lokatie Elisabeth

Amersfoort, 3816 CP, Netherlands

Location

Diabeter

Rotterdam, 3011 TG, Netherlands

Location

Orbis Medisch Centrum

Sittard-Geleen, 6162, Netherlands

Location

Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis

The Hague, 2566 MJ, Netherlands

Location

University Medical Centre Ljubljana, Department of Pediatric Endocrinology

Ljubljana, 1525, Slovenia

Location

Hospital Materno-Infantil Vall Hebrón

Barcelona, 08035, Spain

Location

Hospital Materno-Infantil de Cruces

Cruces / Barakaldo, 48903, Spain

Location

Hospital Materno-Infantil Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Materno-Infantil La Paz

Madrid, 28046, Spain

Location

Hospital Materno-Infantil Carlos Haya

Málaga, 29011, Spain

Location

Hospital Materno-Infantil Vírgen del Camino

Pamplona, 31008, Spain

Location

Hospital Materno-Infantil Vírgen del Rocío

Seville, 41013, Spain

Location

Hospital Materno-Infantil Clínico de Valencia

Valencia, 46010, Spain

Location

Hospital Materno-Infantil Miguel Servet

Zaragoza, 50009, Spain

Location

Barn- och ungdomskliniken, Lasarettet

Borås, SE-501 82, Sweden

Location

Barn- och ungdomskliniken, Länssjukhuset

Gävle, SE-801 87, Sweden

Location

Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården

Gothenburg, SE-416 85, Sweden

Location

Barn- och ungdomskliniken, Länssjukhuset

Halmstad, SE-301 85, Sweden

Location

Barn- och ungdomsmedicin, Lasarettet

Helsingborg, SE-251 87, Sweden

Location

Barnkliniken, Hudiksvalls Sjukhus

Hudiksvall, SE-824 81, Sweden

Location

Barn- och ungdomskliniken, Länssjukhuset Ryhov

Jönköping, SE-551 85, Sweden

Location

Barn- och ungdomskliniken, Lasarettet

Kalmar, SE-391 85, Sweden

Location

Barn- och ungdomskliniken, Centralsjukhuset

Karlstad, SE-651 85, Sweden

Location

Barn och ungdomsmedicinska kliniken, Centralsjukhuset

Kristianstad, SE-291 33, Sweden

Location

Barn- och ungdomskliniken, Universitetssjukhuset

Linköping, SE-581 85, Sweden

Location

Barn- och ungdomskliniken, Universitetssjukhuset

Lund, SE-221 85, Sweden

Location

Barn- och ungdomscentrum, Universitetssjukhuset MAS

Malmo, SE-205 02, Sweden

Location

Barn- och ungdomskliniken, Vrinnevi sjukhus

Norrköping, SE-601 83, Sweden

Location

Barn- och ungdomskliniken, Universitetssjukhuset

Örebro, SE-701 85, Sweden

Location

Sachsska Barnsjukhuset, Södersjukhuset

Stockholm, SE-118 83, Sweden

Location

Barn- och ungdomskliniken, NU-sjukvården/NÄL

Trollhättan, SE-461 85, Sweden

Location

Barn- och ungdomskliniken, Uddevalla Sjukhus

Uddevalla, SE-451 80, Sweden

Location

Barn- och ungdomskliniken, Centrallasarettet

Vaxjo, SE-351 85, Sweden

Location

Barn- och ungdomskliniken, Centrallasarettet

Västerås, SE-721 89, Sweden

Location

Maternal & Child Health Sciences, University of Dundee

Dundee, DD1 9SY, United Kingdom

Location

Children's Admin Centre

Leicester, LE1 5WW, United Kingdom

Location

Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry

London, E1 2AT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 28357504 DERIVED

• 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.

  PMID: 24302596 DERIVED

• 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.

  PMID: 22296077 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Johnny Ludvigsson, MD, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 10, 2011

Record last verified: 2011-10

Locations

FR (11); DE (7); IT (9); NL (4); ES (9); SE (20); SL (1); GB (3); FI (6)