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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615264
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Information provided by (Responsible Party):
Andromeda Biotech Ltd.

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: DiaPep277 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2005
Primary Completion Date : September 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months [ Time Frame: Baseline and 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 :
  1. Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months [ Time Frame: Baseline and 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615264

  Hide Study Locations
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
Pohjois-Karjala projektin tutkimussäätiö
Joensuu, Finland, 80100
Tutkimusyksikkö Oulu
Oulu, Finland, 90220
Vantaa, Finland, 01300
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
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
Laiko hospital
Athens, Greece, 11572
Wolfson Medical Centre
Holon, Israel, 58100
Hadassah University Hospital
Jerusalem, Israel, 91120
Schneider Children's Medical Centre
Petach Tikva, Israel, 49202
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
Helderberg Clinical Trials Unit
Cape Town, South Africa, 7129
New Groote Schuur Hospital
Cape Town, South Africa, 7925
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
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.
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Andromeda Biotech Ltd. Identifier: NCT00615264     History of Changes
Other Study ID Numbers: 901
First Posted: February 14, 2008    Key Record Dates
Results First Posted: June 6, 2016
Last Update Posted: June 6, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs