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Clinical Trial Details

Trial ID: L4996
Source ID: NCT01103284
Associated Drug: Diapep277
Title: Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
Acronym: DIA-AID2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01103284/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: DiaPep277|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months, Change in Beta-cell function, measured as stimulated C-peptide secretion 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: Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%, The percentage of subjects achieving good glycemic control, i.e. an HbA1c \<7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end., 24 and 25 months|Frequency of Hypoglycemic Events, Total number of days with at least one hypoglycemic event recorded, Baseline to 25 Months|Mean Number of Days With at Least One Hypoglycemic Event, Baseline to 25 months | Other: Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study, Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with a daily insulin dose ≤ 0.5 IU/kg at study end., 24 and 25 months
Sponsor/Collaborators: Sponsor: Andromeda Biotech Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 475
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-04
Completion Date: 2014-10
Results First Posted: 2016-05-26
Last Update Posted: 2016-05-26
Locations: Los Gatos, California, 95032, United States|Sutter Gold Medical Foundation, Modesto, California, 95355, United States|San Diego Clinical Trials, San Diego, California, 92120, United States|University of Colorado Hospital - Anschutz Outpatient Pavilion, Aurora, Colorado, 80045, United States|Creekside Endocrine Associates, Inc., Denver, Colorado, 80209, United States|George Washington University Medical Faculty Associates, Washington, District of Columbia, 20037, United States|Innovative Medical Research of South Florida Inc., Aventura, Florida, 33180, United States|DeLand, Florida, 32720, United States|Orlando Diabetes & Endocrine Specialists, P.A., Orlando, Florida, 32825, United States|Tallahassee Endocrine Associates, Tallahassee, Florida, 32308, United States|Diabetes and Hormonal Disease Center, Tampa, Florida, 33613, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States|Kentucky Diabetes Endocrinology Center, Lexington, Kentucky, 40503, United States|Washington University, St. Louis, Missouri, 63110, United States|Palm Medical Research Center, Las Vegas, Nevada, 89148, United States|Soutwest Clinical Research Center, LLC, Santa Fe, New Mexico, 87505, United States|Mountain Diabetes and Endocrine Center, Ashville, North Carolina, 28803, United States|University of North Carolina Diabetes Care Center, Durham, North Carolina, 27703, United States|The Lindner Research Center, The Christ Hospital, Cincinnati, Ohio, 45219, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Legacy Clinical Research & Technology Center, Portland, Oregon, 97210, United States|AM Diabetes & Endocrinology Center, Bartlett, Tennessee, 38133, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Cetero Research, San Antonio, Texas, 78229, United States|Northside Internal Medicine Associates, PS, Spokane, Washington, 99208, United States|Multicare Specialties Research, Tacoma, Washington, 98405, United States|Universitatsklinik fur Innere Medzin I, Landeskrankenhaus, Innsbruck, 6020, Austria|Rudolfstiftung Hospital, Vienna, 1030, Austria|Endocrinological Unit 1st City Clinical Hospital, Minsk, 220013, Belarus|Republican center of Medical Rehabilitation and Balneotherapy, Minsk, 220013, Belarus|Health Institution City Endocrinological Dispensary, Minsk, 220029, Belarus|Belarusian Medical Academy of Postgraduate Education, Minsk, 220096, Belarus|Health Institution Mogilev Diagnostic Center, Mogilov, 212030, Belarus|LMC Endocrinology Centres, Calgary, Alberta, T2H 0K2, Canada|LMC Endocrinology Centres, Oakville, Ontario, L6H 3P1, Canada|LMC Endocrinoly Centres, Toronto, Ontario, M4R 2G4, Canada|Fakultni nemocnice Kralovske Vinohrady - II. internal department, Prague, 10035, Czech Republic|IKEM/Diabetes Centre/Videnska, Prague, 4140, Czech Republic|Tutkimusyksikko, Oulu, 90220, Finland|DDZ Studienzentrum Deutsches Diabetes Zentrum, Dusseldorf, 40225, Germany|Universitatsklinikum Giessen, Giessen, 35392, Germany|Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult, Hannover, 30173, Germany|Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin, Munchen, 80804, Germany|Institut für Diabetesforschung Münster GmbH, Munster, 48145, Germany|University of Szeged Faculty of Medicin, Szeged, H-6700, Hungary|Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum, Veszprem, 8200, Hungary|Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum, Zalaegerszeg, 9000, Hungary|Diabetes Clinic Soroka University, Beer Sheva, 84101, Israel|Soroka University Medical Center, Beer Sheva, 84101, Israel|Rambam Medical Cent, Haifa, 31096, Israel|Wolfson Medical Center, Holon, Israel|Hadassah Medical Center, Jerusalem, Israel|Institute for Endocrinology and Diabetes Schneider Children's MC, Petach-Tiqva, 49202, Israel|. Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm, Palermo, 90127, Italy|Dept. of Endocrinology and Diabetes University Campus Bio-Medico, Rome, 00128, Italy|University La Sapienza, Policlinico Umberto I, Rome, 00161, Italy|Private Clinic JSC 'Kristavita', Jonava, 55201, Lithuania|Kaunas Medical University Hospital, Kaunas, 50009, Lithuania|Public Institution 'Seskines Outpatient Clinic', Vilnius, 07156, Lithuania|Vilnius Medical University Hospital, Santariskiu Clinic's, Vilnius, 08661, Lithuania|NZOZ OmniMed, Lodz, 93-338, Poland|State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical, Chelyabinsk, 454021, Russian Federation|Kemerovo Regional Clinical Hospital, Kemerovo, 650066, Russian Federation|Endocrinological scientific center of Rosmedtechnology, Moscow, 117036, Russian Federation|SEIAPE Endocrinology and Diabetology, Moscow, 125367, Russian Federation|City Clinical Hospital #81, Endocrinology Department, Moscow, 127644, Russian Federation|Clinic of New Medical Technology, LLC, Moscow, 140091, Russian Federation|State Healthcare Institution (SHI) "Nizhegorodskaya, Nizhni Novgorod, 603126, Russian Federation|State Healthcare Institution Perm Region Clinical Hospital, Perm, 614990, Russian Federation|Limited Liability Company (LLC), Diabetes Center, Samara, 443067, Russian Federation|State Educational Institution of Higher Professional Education, St Petersburg, 197022, Russian Federation|St. Petersburg State Healthcare Institution, St. Petersburg, 194354, Russian Federation|Siberian State Medical University of Roszdrav, Tomsk, 634050, Russian Federation|Complejo Hospitalario Universitario Insular Materno-Infantil, Las Palmas de Gran Canaria, 35016, Spain|Hospital Universitari Arnau de Vilanova, Lleida, 25198, Spain
URL: https://clinicaltrials.gov/show/NCT01103284

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress