search
Back to results

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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DiaPep277
Placebo
Sponsored by
Andromeda Biotech Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rudolfstiftung Hospital
  • Faculty Hospital
  • Faculty hospital Motol.
  • IKEM/Diabetes Centre
  • Pohjois-Karjala projektin tutkimussäätiö
  • Tutkimusyksikkö Oulu
  • Diabetestutkimus
  • CHU de Grenoble
  • Hopital Edouard Herriot
  • Hopital La Timone
  • CHU de Nîmes/ Hôpital Caremeau
  • Universitätsklinikum
  • Diabetes Centre for Children and Adolescents
  • Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
  • Laiko hospital
  • Wolfson Medical Centre
  • Hadassah University Hospital
  • Schneider Children's Medical Centre
  • Universita' degli Studi di Bari
  • Ex Istituto di clinica medica
  • University Campus Bio-Medico
  • Università "La Sapienza"
  • Istituto Clinico Humanitas
  • Helderberg Clinical Trials Unit
  • New Groote Schuur Hospital
  • 102 Parklands Medical Centre
  • Donald Gordon Medical Center
  • Centre for Diabetes and Endocrinology
  • Hospital de la Santa Creu
  • Hospital Universitari Arnau de Vilanova
  • Hospital de Sabadell
  • Hospital Nuestra Señora de La Candelaria
  • St. Bartholomew's Hospital
  • Royal Shrewsbury Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DiaPep277

Placebo

Arm Description

DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.

Mannitol 40 mg in 0.5 mL lipid emulsion.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 4, 2008
Last Updated
May 25, 2016
Sponsor
Andromeda Biotech Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00615264
Brief Title
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andromeda Biotech Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DiaPep277
Arm Type
Experimental
Arm Description
DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Mannitol 40 mg in 0.5 mL lipid emulsion.
Intervention Type
Drug
Intervention Name(s)
DiaPep277
Intervention Description
1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
Primary Outcome Measure Information:
Title
Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months
Description
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.
Time Frame
Baseline and 24 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months
Description
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.
Time Frame
Baseline and 24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itamar Raz, MD
Organizational Affiliation
Hadassah Medical Center, Jerusalem
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo Pozzilli, MD
Organizational Affiliation
Universita Campus Bio-Medico, Rome
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francois Bonici, MD
Organizational Affiliation
New Groote Schuur Hospital, Cape Town
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Linn, MD
Organizational Affiliation
Universitätsklinikum, Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rudolfstiftung Hospital
City
Vienna
ZIP/Postal Code
1030
Country
Austria
Facility Name
Faculty Hospital
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Faculty hospital Motol.
City
Prague
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
IKEM/Diabetes Centre
City
Praha
ZIP/Postal Code
4 140 21
Country
Czech Republic
Facility Name
Pohjois-Karjala projektin tutkimussäätiö
City
Joensuu
ZIP/Postal Code
80100
Country
Finland
Facility Name
Tutkimusyksikkö Oulu
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Diabetestutkimus
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hopital La Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU de Nîmes/ Hôpital Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Universitätsklinikum
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Diabetes Centre for Children and Adolescents
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
City
Munich
ZIP/Postal Code
80804
Country
Germany
Facility Name
Laiko hospital
City
Athens
ZIP/Postal Code
11572
Country
Greece
Facility Name
Wolfson Medical Centre
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Schneider Children's Medical Centre
City
Petach Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Universita' degli Studi di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ex Istituto di clinica medica
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
University Campus Bio-Medico
City
Rome
ZIP/Postal Code
00155
Country
Italy
Facility Name
Università "La Sapienza"
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Helderberg Clinical Trials Unit
City
Cape Town
ZIP/Postal Code
7129
Country
South Africa
Facility Name
New Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
102 Parklands Medical Centre
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Donald Gordon Medical Center
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Centre for Diabetes and Endocrinology
City
Johannesburg
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Hospital de la Santa Creu
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
ZIP/Postal Code
5198
Country
Spain
Facility Name
Hospital de Sabadell
City
Sabadell
Country
Spain
Facility Name
Hospital Nuestra Señora de La Candelaria
City
Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
St. Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24757230
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.
Results Reference
derived
PubMed Identifier
24408401
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.
Results Reference
derived

Learn more about this trial

Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients

We'll reach out to this number within 24 hrs