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

October 7, 2011 updated by: Diamyd Therapeutics AB

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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
  • GAD-Alum
  • GAD65
  • GAD
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-Alum
  • GAD65
  • 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, 30, 90 and 270.
Other Names:
  • Diamyd
  • GAD-Alum
  • GAD65
  • GAD
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-Alum
  • GAD65
  • GAD
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Meal stimulated C-peptide (area under the curve)
Time Frame: 15 months
15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 15 months
15 months
Insulin Dose
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diamyd Therapeutics AB

Investigators

  • Principal Investigator: Johnny Ludvigsson, MD, PhD, Linköping University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (ESTIMATE)

July 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D/P3/07/4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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