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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT00615264
First received: February 4, 2008
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Drug: DiaPep277
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Andromeda Biotech Ltd.:

Primary Outcome Measures:
  • Stimulated C-peptide, as determined by change from baseline in C-peptide AUC measured in a 20 minutes glucagon-stimulated test (GST) [ Time Frame: 0, to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of patients that achieve HbA1c=<7% [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • mixed-meal stimulated C-peptide secretion, as measured bychange in AUC from baseline to 24 months [ Time Frame: 0, 6, 12, 18, 24 ] [ Designated as safety issue: No ]
  • Fasting C-peptide, as measured by change from baseline to 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 457
Study Start Date: September 2005
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DiaPep277 1.0 mg + 40 mg Mannitol in 0.5ml 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: 2
Mannitol 40 mg in 0.5ml lipid emulsion.
Drug: Placebo
Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615264

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

No publications provided by Andromeda Biotech Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT00615264     History of Changes
Other Study ID Numbers: 901, ISRCTN55429664
Study First Received: February 4, 2008
Last Updated: July 10, 2013
Health Authority: Austria: Federal Ministry for Health and Women
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Italy: Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014