Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients (DIA-AID)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: DiaPep277; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 457
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1030
    • Rudolfstiftung Hospital
• Czech Republic
  • Olomouc, Czech Republic, 775 20
    • Faculty Hospital
  • Prague, Czech Republic, 150 06
    • Faculty hospital Motol.
  • Praha, Czech Republic, 4 140 21
    • IKEM/Diabetes Centre
• Finland
  • Joensuu, Finland, 80100
    • Pohjois-Karjala projektin tutkimussäätiö
  • Oulu, Finland, 90220
    • Tutkimusyksikkö Oulu
  • Vantaa, Finland, 01300
    • Diabetestutkimus
• France
  • Grenoble, France, 38043
    • Chu de Grenoble
  • Lyon, France, 69003
    • Hôpital Edouard Herriot
  • Marseille, France, 13005
    • Hôpital La Timone
  • Nimes, France, 30029
    • CHU de Nîmes/ Hôpital Caremeau
• Germany
  • Giessen, Germany, 35392
    • Universitätsklinikum
  • Hannover, Germany, 30173
    • Diabetes Centre for Children and Adolescents
  • Munich, Germany, 80804
    • Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
• Greece
  • Athens, Greece, 11572
    • Laiko Hospital
• Israel
  • Holon, Israel, 58100
    • Wolfson Medical Centre
  • Jerusalem, Israel, 91120
    • Hadassah University Hospital
  • Petach Tikva, Israel, 49202
    • Schneider Children's Medical Centre
• Italy
  • Bari, Italy, 70124
    • Universita' degli Studi di Bari
  • Palermo, Italy, 90127
    • Ex Istituto di clinica medica
  • Rome, Italy, 00155
    • University Campus Bio-Medico
  • Rome, Italy, 00161
    • Università "La Sapienza"
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
• South Africa
  • Cape Town, South Africa, 7129
    • Helderberg Clinical Trials Unit
  • Cape Town, South Africa, 7925
    • New Groote Schuur Hospital
  • Durban, South Africa, 4091
    • 102 Parklands Medical Centre
  • Johannesburg, South Africa, 2198
    • Centre for Diabetes and Endocrinology
  • Johannesburg, South Africa, 2193
    • Donald Gordon Medical Center
• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu
  • Lleida, Spain, 5198
    • Hospital Universitari Arnau de Vilanova
  • Sabadell, Spain
    • Hospital de Sabadell
  • Tenerife, Spain, 38010
    • Hospital Nuestra Señora de la Candelaria
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • St. Bartholomew's Hospital
  • Shrewsbury, United Kingdom, SY3 8XQ
    • Royal Shrewsbury Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DiaPep277; DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.	Drug: DiaPep277; 1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
Placebo Comparator: Placebo; Mannitol 40 mg in 0.5 mL lipid emulsion.	Drug: Placebo; Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months	Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.	Baseline and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months	Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.	Baseline and 24 Months

Collaborators and Investigators

• Sponsor: Andromeda Biotech Ltd.
• Investigators: Principal Investigator: Paolo Pozzilli, MD, Universita Campus Bio-Medico, Rome; Principal Investigator: Francois Bonici, MD, New Groote Schuur Hospital, Cape Town; Principal Investigator: Thomas Linn, MD, Universitätsklinikum, Giessen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 4, 2008
• First Submitted That Met QC Criteria: February 13, 2008
• First Posted (Estimate): February 14, 2008

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 901; ISRCTN55429664