Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients

Type 1 Diabetes Clinical Trial

— DIA-AID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615264
• Other study ID #: 901
• Secondary ID: ISRCTN55429664
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2008
• Last updated: July 10, 2013
• Start date: September 2005
• Est. completion date: January 2012

Study information

• Verified date: July 2013
• Source: Andromeda Biotech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesIsrael: The Israel National Institute for Health Policy Research and Health Services ResearchItaly: Ministry of HealthSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

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.

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, Type 1
• Type 1 Diabetes

Intervention

Drug:
• DiaPep277
1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
• Placebo
Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

Locations

Country	Name	City	State
Austria	Rudolfstiftung Hospital	Vienna
Czech Republic	Faculty Hospital	Olomouc
Czech Republic	Faculty hospital Motol.	Prague
Czech Republic	IKEM/Diabetes Centre	Praha
Finland	Pohjois-Karjala projektin tutkimussäätiö	Joensuu
Finland	Tutkimusyksikkö Oulu	Oulu
Finland	Diabetestutkimus	Vantaa
France	CHU de Grenoble	Grenoble
France	Hopital Edouard Herriot	Lyon
France	Hopital La Timone	Marseille
France	CHU de Nîmes/ Hôpital Caremeau	Nimes
Germany	Universitätsklinikum	Giessen
Germany	Diabetes Centre for Children and Adolescents	Hannover
Germany	Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin	Munich
Greece	Laiko hospital	Athens
Israel	Wolfson Medical Centre	Holon
Israel	Hadassah University Hospital	Jerusalem
Israel	Schneider Children's Medical Centre	Petach Tikva
Italy	Universita' degli Studi di Bari	Bari
Italy	Ex Istituto di clinica medica	Palermo
Italy	Università "La Sapienza"	Rome
Italy	University Campus Bio-Medico	Rome
Italy	Istituto Clinico Humanitas	Rozzano
South Africa	Helderberg Clinical Trials Unit	Cape Town
South Africa	New Groote Schuur Hospital	Cape Town
South Africa	102 Parklands Medical Centre	Durban
South Africa	Centre for Diabetes and Endocrinology	Johannesburg
South Africa	Donald Gordon Medical Center	Johannesburg
Spain	Hospital de la Santa Creu	Barcelona
Spain	Hospital Universitari Arnau de Vilanova	Lleida
Spain	Hospital de Sabadell	Sabadell
Spain	Hospital Nuestra Señora de La Candelaria	Tenerife
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury

Sponsors (1)

Lead Sponsor	Collaborator
Andromeda Biotech Ltd.

Countries where clinical trial is conducted

Austria,  Czech Republic,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulated C-peptide, as determined by change from baseline in C-peptide AUC measured in a 20 minutes glucagon-stimulated test (GST)		0, to 24 months	No
Secondary	Percent of patients that achieve HbA1c=<7%		0, 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	mixed-meal stimulated C-peptide secretion, as measured bychange in AUC from baseline to 24 months		0, 6, 12, 18, 24	No
Secondary	Fasting C-peptide, as measured by change from baseline to 24 months.		24 months	No