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

Type 1 Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00723411
• Other study ID #: D/P3/07/4
• Status: Terminated
• Phase: Phase 3
• First received: July 24, 2008
• Last updated: October 7, 2011
• Start date: July 2008
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Diamyd Therapeutics AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review BoardFinland: Finnish Medicines AgencyFinland: Ethics CommitteeSlovenia: Agency for Medicinal Products - Ministry of HealthSlovenia: Ethics CommitteeSpain: Spanish Agency of MedicinesSpain: Comité Ético de Investigación ClínicaNetherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Italy: The Italian Medicines AgencyItaly: Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionFrance: Agence francaise de sécurité sanitaire des produits de santé, (afssaps)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 334
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 20 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
• rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
• Placebo
Placebo injected subcutaneously at days 1, 30, 90 and 270

Locations

Country	Name	City	State
Finland	Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala	Helsinki
Finland	Kuopion yliopistollinen sairaala, Lasten klinikka	Kuopio
Finland	Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka	Oulu
Finland	Seinäjoen keskussairaala, Lastentautien poliklinikka	Seinäjoki
Finland	Tampereen yliopistollinen sairaala, Lasten klinikka	Tampere
Finland	Turun yliopistollinen keskussairaala, Lastentautien Klinikka	Turku
France	Medecine B	Angers
France	Centre Hospitalier Universitaire de Besançon	Besançon
France	Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique	Bordeaux
France	Hôpital Jeanne de Flandre Sce Pédiatrie	Lille
France	CHU Timone Enfants, Service de pédiatrie multidisciplinaire	Marseilles
France	CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1	Montpellier
France	C.H.U.Serv.Pediatrie	Nantes
France	Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,	Paris
France	Hopital Robert Debré, Service d'Endocrinologie	Paris
France	CHU Rennes	Rennes
France	Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique	Toulouse
Germany	Charité Campus Virchow Childrens Hospital	Berlin
Germany	DRK Kliniken Westend	Berlin
Germany	KHK Wilhelmstift	Hamburg-Rahlstedt
Germany	Hannover Kinderkrankenhaus auf der Bult	Hannover
Germany	Klinik und Poliklinik f?r Kinder und Jugendliche der Universität Leipzig	Leipzig
Germany	Klinik f?r Kinder- und Jugendmedizin	M?nchen
Germany	Universitätsklinik f?r Kinder- und Jugendmedizin, T?bingen	T?bingen
Italy	Unità Operativa di Pediatria, Policlinico	Bologna
Italy	Struttura Complessa di Diabetologia, Ospedale S. Michele	Cagliari
Italy	S.S. Annunziata, Clinica Pediatrica	Chieti
Italy	Clinica Pediatrica, Università di Genova	Genova
Italy	Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco	Milano
Italy	Reparto di Pediatria, Ospedale S. Raffaele	Milano
Italy	Azienda Ospedaliero, Universitaria di Parma, Pediatria	Parma
Italy	Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia	Roma
Italy	Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita	Torino
Netherlands	Meander Medisch Centrum, Lokatie Elisabeth	Amersfoort
Netherlands	Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis	Den Haag
Netherlands	Diabeter	Rotterdam
Netherlands	Orbis Medisch Centrum	Sittard-Geleen
Slovenia	University Medical Centre Ljubljana, Department of Pediatric Endocrinology	Ljubljana
Spain	Hospital Materno-Infantil Vall Hebrón	Barcelona
Spain	Hospital Materno-Infantil de Cruces	Cruces / Barakaldo
Spain	Hospital Materno-Infantil La Paz	Madrid
Spain	Hospital Materno-Infantil Ramón y Cajal	Madrid
Spain	Hospital Materno-Infantil Carlos Haya	Málaga
Spain	Hospital Materno-Infantil Vírgen del Camino	Pamplona
Spain	Hospital Materno-Infantil Vírgen del Rocío	Sevilla
Spain	Hospital Materno-Infantil Clínico de Valencia	Valencia
Spain	Hospital Materno-Infantil Miguel Servet	Zaragoza
Sweden	Barn- och ungdomskliniken, Lasarettet	Borås
Sweden	Barn- och ungdomskliniken, Länssjukhuset	Gävle
Sweden	Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården	Göteborg
Sweden	Barn- och ungdomskliniken, Länssjukhuset	Halmstad
Sweden	Barn- och ungdomsmedicin, Lasarettet	Helsingborg
Sweden	Barnkliniken, Hudiksvalls Sjukhus	Hudiksvall
Sweden	Barn- och ungdomskliniken, Länssjukhuset Ryhov	Jönköping
Sweden	Barn- och ungdomskliniken, Lasarettet	Kalmar
Sweden	Barn- och ungdomskliniken, Centralsjukhuset	Karlstad
Sweden	Barn och ungdomsmedicinska kliniken, Centralsjukhuset	Kristianstad
Sweden	Barn- och ungdomskliniken, Universitetssjukhuset	Linköping
Sweden	Barn- och ungdomskliniken, Universitetssjukhuset	Lund
Sweden	Barn- och ungdomscentrum, Universitetssjukhuset MAS	Malmö
Sweden	Barn- och ungdomskliniken, Vrinnevi sjukhus	Norrköping
Sweden	Barn- och ungdomskliniken, Universitetssjukhuset	Örebro
Sweden	Sachsska Barnsjukhuset, Södersjukhuset	Stockholm
Sweden	Barn- och ungdomskliniken, NU-sjukvården/NÄL	Trollhättan
Sweden	Barn- och ungdomskliniken, Uddevalla Sjukhus	Uddevalla
Sweden	Barn- och ungdomskliniken, Centrallasarettet	Västerås
Sweden	Barn- och ungdomskliniken, Centrallasarettet	Växjö
United Kingdom	Maternal & Child Health Sciences, University of Dundee	Dundee
United Kingdom	Children's Admin Centre	Leicester
United Kingdom	Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry	London

Sponsors (1)

Lead Sponsor	Collaborator
Diamyd Therapeutics AB

Countries where clinical trial is conducted

Finland,  France,  Germany,  Italy,  Netherlands,  Slovenia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meal stimulated C-peptide (area under the curve)		15 months	No
Secondary	HbA1c		15 months	No
Secondary	Insulin Dose		15 months	No