Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
- Registration Number
- NCT00615264
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 457
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Mannitol 40 mg in 0.5 mL lipid emulsion. DiaPep277 DiaPep277 DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
- Primary Outcome Measures
Name Time Method Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months 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
Name Time Method Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months 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.
Trial Locations
- Locations (34)
Faculty hospital Motol.
🇨🇿Prague, Czech Republic
Schneider Children's Medical Centre
🇮🇱Petach Tikva, Israel
Universita' degli Studi di Bari
🇮🇹Bari, Italy
IKEM/Diabetes Centre
🇨🇿Praha, Czech Republic
Pohjois-Karjala projektin tutkimussäätiö
🇫🇮Joensuu, Finland
Diabetestutkimus
🇫🇮Vantaa, Finland
Laiko hospital
🇬🇷Athens, Greece
Hospital de la Santa Creu
🇪🇸Barcelona, Spain
Tutkimusyksikkö Oulu
🇫🇮Oulu, Finland
Ex Istituto di clinica medica
🇮🇹Palermo, Italy
University Campus Bio-Medico
🇮🇹Rome, Italy
Universitätsklinikum
🇩🇪Giessen, Germany
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Rudolfstiftung Hospital
🇦🇹Vienna, Austria
CHU de Grenoble
🇫🇷Grenoble, France
Helderberg Clinical Trials Unit
🇿🇦Cape Town, South Africa
Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
🇩🇪Munich, Germany
Università "La Sapienza"
🇮🇹Rome, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Wolfson Medical Centre
🇮🇱Holon, Israel
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, United Kingdom
New Groote Schuur Hospital
🇿🇦Cape Town, South Africa
Hopital Edouard Herriot
🇫🇷Lyon, France
Hospital de Sabadell
🇪🇸Sabadell, Spain
Faculty Hospital
🇨🇿Olomouc, Czech Republic
St. Bartholomew's Hospital
🇬🇧London, United Kingdom
Hopital La Timone
🇫🇷Marseille, France
102 Parklands Medical Centre
🇿🇦Durban, South Africa
Hospital Nuestra Señora de La Candelaria
🇪🇸Tenerife, Spain
Diabetes Centre for Children and Adolescents
🇩🇪Hannover, Germany
CHU de Nîmes/ Hôpital Caremeau
🇫🇷Nimes, France
Donald Gordon Medical Center
🇿🇦Johannesburg, South Africa
Centre for Diabetes and Endocrinology
🇿🇦Johannesburg, South Africa
Hadassah University Hospital
🇮🇱Jerusalem, Israel