Type 1 Diabetes Clinical Trial
— DIA-AIDOfficial 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
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Andromeda Biotech Ltd. |
Austria, Czech Republic, Finland, France, Germany, Greece, Israel, Italy, South Africa, Spain, United Kingdom,
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 |
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