Clinical trial NCT00615264: Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
Official title: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Lead sponsor: Andromeda Biotech Ltd.
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 457
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of type 1 diabetes for up to 3 months at screening
* Insulin dependency
* Fasting C-peptide levels \>= 0.22 nmol/L
* Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)

Exclusion Criteria:

* Pregnancy or intent to conceive in the next 2 years
* Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
* Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.

Primary outcomes:
measure: Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months
timeFrame: Baseline and 24 Months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Rudolfstiftung Hospital
city: Olomouc
country: Czech Republic
facility: Faculty Hospital
city: Prague
country: Czech Republic
facility: Faculty hospital Motol.
city: Praha
country: Czech Republic
facility: IKEM/Diabetes Centre
city: Joensuu
country: Finland
facility: Pohjois-Karjala projektin tutkimussäätiö
city: Oulu
country: Finland
facility: Tutkimusyksikkö Oulu
city: Vantaa
country: Finland
facility: Diabetestutkimus
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: Hopital La Timone
city: Nimes
country: France
facility: CHU de Nîmes/ Hôpital Caremeau
city: Giessen
country: Germany
facility: Universitätsklinikum
city: Hannover
country: Germany
facility: Diabetes Centre for Children and Adolescents
city: Munich
country: Germany
facility: Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
city: Athens
country: Greece
facility: Laiko hospital
city: Holon
country: Israel
facility: Wolfson Medical Centre
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Centre
city: Bari
country: Italy
facility: Universita' degli Studi di Bari
city: Palermo
country: Italy
facility: Ex Istituto di clinica medica
city: Rome
country: Italy
facility: University Campus Bio-Medico
city: Rome
country: Italy
facility: Università "La Sapienza"
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Cape Town
country: South Africa
facility: Helderberg Clinical Trials Unit
city: Cape Town
country: South Africa
facility: New Groote Schuur Hospital
city: Durban
country: South Africa
facility: 102 Parklands Medical Centre
city: Johannesburg
country: South Africa
facility: Donald Gordon Medical Center
city: Johannesburg
country: South Africa
facility: Centre for Diabetes and Endocrinology
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Sabadell
country: Spain
facility: Hospital de Sabadell
city: Tenerife
country: Spain
facility: Hospital Nuestra Señora de La Candelaria
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
Study officials:
affiliation: Hadassah Medical Center, Jerusalem
name: Itamar Raz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita Campus Bio-Medico, Rome
name: Paolo Pozzilli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New Groote Schuur Hospital, Cape Town
name: Francois Bonici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum, Giessen
name: Thomas Linn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raz I, Ziegler AG, Linn T, Schernthaner G, Bonnici F, Distiller LA, Giordano C, Giorgino F, de Vries L, Mauricio D, Prochazka V, Wainstein J, Elias D, Avron A, Tamir M, Eren R, Peled D, Dagan S, Cohen IR, Pozzilli P; DIA-AID 1 Writing Group. Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial. Diabetes Care. 2014;37(5):1392-400. doi: 10.2337/dc13-1391.
citation: Pozzilli P, Raz I, Peled D, Elias D, Avron A, Tamir M, Eren R, Dagan S, Cohen IR. Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal. Diabetes Care. 2014;37(5):1384-91. doi: 10.2337/dc13-1392. Epub 2014 Jan 9.