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Clinical Trial Details

Trial ID: L5080
Source ID: NCT00615264
Associated Drug: Diapep277
Title: Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
Acronym: DIA-AID
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00615264/results
Conditions: Type 1 Diabetes
Interventions: DRUG: DiaPep277|DRUG: Placebo
Outcome Measures: Primary: 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., Baseline and 24 months | Secondary: 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., Baseline and 24 Months
Sponsor/Collaborators: Sponsor: Andromeda Biotech Ltd.
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 457
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2005-09
Completion Date: 2012-01
Results First Posted: 2016-06-06
Last Update Posted: 2016-06-06
Locations: Rudolfstiftung Hospital, Vienna, 1030, Austria|Faculty Hospital, Olomouc, 775 20, Czech Republic|Faculty hospital Motol., Prague, 150 06, Czech Republic|IKEM/Diabetes Centre, Praha, 4 140 21, Czech Republic|Pohjois-Karjala projektin tutkimussäätiö, Joensuu, 80100, Finland|Tutkimusyksikkö Oulu, Oulu, 90220, Finland|Diabetestutkimus, Vantaa, 01300, Finland|CHU de Grenoble, Grenoble, 38043, France|Hopital Edouard Herriot, Lyon, 69003, France|Hopital La Timone, Marseille, 13005, France|CHU de Nîmes/ Hôpital Caremeau, Nimes, 30029, France|Universitätsklinikum, Giessen, 35392, Germany|Diabetes Centre for Children and Adolescents, Hannover, 30173, Germany|Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin, Munich, 80804, Germany|Laiko hospital, Athens, 11572, Greece|Wolfson Medical Centre, Holon, 58100, Israel|Hadassah University Hospital, Jerusalem, 91120, Israel|Schneider Children's Medical Centre, Petach Tikva, 49202, Israel|Universita' degli Studi di Bari, Bari, 70124, Italy|Ex Istituto di clinica medica, Palermo, 90127, Italy|University Campus Bio-Medico, Rome, 00155, Italy|Università "La Sapienza", Rome, 00161, Italy|Istituto Clinico Humanitas, Rozzano, 20089, Italy|Helderberg Clinical Trials Unit, Cape Town, 7129, South Africa|New Groote Schuur Hospital, Cape Town, 7925, South Africa|102 Parklands Medical Centre, Durban, 4091, South Africa|Donald Gordon Medical Center, Johannesburg, 2193, South Africa|Centre for Diabetes and Endocrinology, Johannesburg, 2198, South Africa|Hospital de la Santa Creu, Barcelona, 08041, Spain|Hospital Universitari Arnau de Vilanova, Lleida, 5198, Spain|Hospital de Sabadell, Sabadell, Spain|Hospital Nuestra Señora de La Candelaria, Tenerife, 38010, Spain|St. Bartholomew's Hospital, London, EC1A 7BE, United Kingdom|Royal Shrewsbury Hospital, Shrewsbury, SY3 8XQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00615264

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