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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rhGAD65
rhGAD65
Placebo
Sponsored by
Diamyd Therapeutics AB
About
Eligibility
Locations
Arms
Outcomes
Full info

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

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

A

B

C

Arm Description

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.

Outcomes

Primary Outcome Measures

Meal stimulated C-peptide (area under the curve)

Secondary Outcome Measures

HbA1c
Insulin Dose

Full Information

First Posted
July 24, 2008
Last Updated
October 7, 2011
Sponsor
Diamyd Therapeutics AB
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1. Study Identification

Unique Protocol Identification Number
NCT00723411
Brief Title
A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)
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 Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Why Stopped
The primary endpoint at 15 months was not met.
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diamyd Therapeutics AB

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.
Intervention Type
Drug
Intervention Name(s)
rhGAD65
Other Intervention Name(s)
Diamyd, GAD65, GAD-Alum, GAD
Intervention Description
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
Intervention Type
Drug
Intervention Name(s)
rhGAD65
Other Intervention Name(s)
Diamyd, GAD, GAD65, GAD-Alum
Intervention Description
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injected subcutaneously at days 1, 30, 90 and 270
Primary Outcome Measure Information:
Title
Meal stimulated C-peptide (area under the curve)
Time Frame
15 months
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
15 months
Title
Insulin Dose
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnny Ludvigsson, MD, PhD
Organizational Affiliation
Linköping University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala
City
Helsinki
ZIP/Postal Code
FI-00029
Country
Finland
Facility Name
Kuopion yliopistollinen sairaala, Lasten klinikka
City
Kuopio
ZIP/Postal Code
FI-70211
Country
Finland
Facility Name
Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka
City
Oulu
ZIP/Postal Code
FI-90029
Country
Finland
Facility Name
Seinäjoen keskussairaala, Lastentautien poliklinikka
City
Seinäjoki
ZIP/Postal Code
FI-60220
Country
Finland
Facility Name
Tampereen yliopistollinen sairaala, Lasten klinikka
City
Tampere
ZIP/Postal Code
FI-33521
Country
Finland
Facility Name
Turun yliopistollinen keskussairaala, Lastentautien Klinikka
City
Turku
ZIP/Postal Code
FI-20521
Country
Finland
Facility Name
Medecine B
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Jeanne de Flandre Sce Pédiatrie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Timone Enfants, Service de pédiatrie multidisciplinaire
City
Marseilles
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
C.H.U.Serv.Pediatrie
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Robert Debré, Service d'Endocrinologie
City
Paris
ZIP/Postal Code
3319
Country
France
Facility Name
Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique
City
Toulouse
ZIP/Postal Code
70034
Country
France
Facility Name
Charité Campus Virchow Childrens Hospital
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
DRK Kliniken Westend
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
KHK Wilhelmstift
City
Hamburg-Rahlstedt
ZIP/Postal Code
22149
Country
Germany
Facility Name
Hannover Kinderkrankenhaus auf der Bult
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinik fȕr Kinder- und Jugendmedizin
City
Mȕnchen
ZIP/Postal Code
80804
Country
Germany
Facility Name
Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen
City
Tȕbingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Unità Operativa di Pediatria, Policlinico
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Struttura Complessa di Diabetologia, Ospedale S. Michele
City
Cagliari
ZIP/Postal Code
09134
Country
Italy
Facility Name
S.S. Annunziata, Clinica Pediatrica
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Clinica Pediatrica, Università di Genova
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Reparto di Pediatria, Ospedale S. Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliero, Universitaria di Parma, Pediatria
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Meander Medisch Centrum, Lokatie Elisabeth
City
Amersfoort
ZIP/Postal Code
3816 CP
Country
Netherlands
Facility Name
Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis
City
Den Haag
ZIP/Postal Code
2566 MJ
Country
Netherlands
Facility Name
Diabeter
City
Rotterdam
ZIP/Postal Code
3011 TG
Country
Netherlands
Facility Name
Orbis Medisch Centrum
City
Sittard-Geleen
ZIP/Postal Code
6162
Country
Netherlands
Facility Name
University Medical Centre Ljubljana, Department of Pediatric Endocrinology
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Facility Name
Hospital Materno-Infantil Vall Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Materno-Infantil de Cruces
City
Cruces / Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Materno-Infantil Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Materno-Infantil La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Materno-Infantil Carlos Haya
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Materno-Infantil Vírgen del Camino
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Materno-Infantil Vírgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Materno-Infantil Clínico de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Materno-Infantil Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Barn- och ungdomskliniken, Lasarettet
City
Borås
ZIP/Postal Code
SE-501 82
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Länssjukhuset
City
Gävle
ZIP/Postal Code
SE-801 87
Country
Sweden
Facility Name
Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården
City
Göteborg
ZIP/Postal Code
SE-416 85
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Länssjukhuset
City
Halmstad
ZIP/Postal Code
SE-301 85
Country
Sweden
Facility Name
Barn- och ungdomsmedicin, Lasarettet
City
Helsingborg
ZIP/Postal Code
SE-251 87
Country
Sweden
Facility Name
Barnkliniken, Hudiksvalls Sjukhus
City
Hudiksvall
ZIP/Postal Code
SE-824 81
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Länssjukhuset Ryhov
City
Jönköping
ZIP/Postal Code
SE-551 85
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Lasarettet
City
Kalmar
ZIP/Postal Code
SE-391 85
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Centralsjukhuset
City
Karlstad
ZIP/Postal Code
SE-651 85
Country
Sweden
Facility Name
Barn och ungdomsmedicinska kliniken, Centralsjukhuset
City
Kristianstad
ZIP/Postal Code
SE-291 33
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Universitetssjukhuset
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Universitetssjukhuset
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Facility Name
Barn- och ungdomscentrum, Universitetssjukhuset MAS
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Vrinnevi sjukhus
City
Norrköping
ZIP/Postal Code
SE-601 83
Country
Sweden
Facility Name
Sachsska Barnsjukhuset, Södersjukhuset
City
Stockholm
ZIP/Postal Code
SE-118 83
Country
Sweden
Facility Name
Barn- och ungdomskliniken, NU-sjukvården/NÄL
City
Trollhättan
ZIP/Postal Code
SE-461 85
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Uddevalla Sjukhus
City
Uddevalla
ZIP/Postal Code
SE-451 80
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Centrallasarettet
City
Västerås
ZIP/Postal Code
SE-721 89
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Centrallasarettet
City
Växjö
ZIP/Postal Code
SE-351 85
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Universitetssjukhuset
City
Örebro
ZIP/Postal Code
SE-701 85
Country
Sweden
Facility Name
Maternal & Child Health Sciences, University of Dundee
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Children's Admin Centre
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry
City
London
ZIP/Postal Code
E1 2AT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28357504
Citation
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.
Results Reference
derived
PubMed Identifier
24302596
Citation
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.
Results Reference
derived
PubMed Identifier
22296077
Citation
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.
Results Reference
derived

Learn more about this trial

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

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