Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
NCT ID: NCT01103284
Last Updated: 2016-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
475 participants
INTERVENTIONAL
2010-04-30
2014-10-31
Brief Summary
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Adults (\>20 years) with newly diagnosed (\<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DiaPep277
Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
DiaPep277
1.0 mg dose in 0.5 mL of solution
Placebo
Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Placebo
40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
Interventions
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DiaPep277
1.0 mg dose in 0.5 mL of solution
Placebo
40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
Eligibility Criteria
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Inclusion Criteria
* Age 20-45 years
* fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L
* BMI between 17 and 30 at screening
Exclusion Criteria
* Diabetes-related complications
* Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids
20 Years
45 Years
ALL
No
Sponsors
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Andromeda Biotech Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Itamar Raz, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Center, Jerusalem
Thomas Linn, MD
Role: PRINCIPAL_INVESTIGATOR
University of Giessen
Paolo P Pozzilli, MB, BS, MD
Role: PRINCIPAL_INVESTIGATOR
University Campus Bio-Medico, Rome
Philip Raskin, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center, Dallas
Locations
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Los Gatos, California, United States
Sutter Gold Medical Foundation
Modesto, California, United States
San Diego Clinical Trials
San Diego, California, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion
Aurora, Colorado, United States
Creekside Endocrine Associates, Inc.
Denver, Colorado, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Innovative Medical Research of South Florida Inc.
Aventura, Florida, United States
DeLand, Florida, United States
Orlando Diabetes & Endocrine Specialists, P.A.
Orlando, Florida, United States
Tallahassee Endocrine Associates
Tallahassee, Florida, United States
Diabetes and Hormonal Disease Center
Tampa, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States
Washington University
St Louis, Missouri, United States
Palm Medical Research Center
Las Vegas, Nevada, United States
Soutwest Clinical Research Center, LLC
Santa Fe, New Mexico, United States
Mountain Diabetes and Endocrine Center
Ashville, North Carolina, United States
University of North Carolina Diabetes Care Center
Durham, North Carolina, United States
The Lindner Research Center, The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Legacy Clinical Research & Technology Center
Portland, Oregon, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, United States
Research Institute of Dallas
Dallas, Texas, United States
Cetero Research
San Antonio, Texas, United States
Northside Internal Medicine Associates, PS
Spokane, Washington, United States
Multicare Specialties Research
Tacoma, Washington, United States
Universitatsklinik fur Innere Medzin I, Landeskrankenhaus
Innsbruck, , Austria
Rudolfstiftung Hospital
Vienna, , Austria
Endocrinological Unit 1st City Clinical Hospital
Minsk, , Belarus
Republican center of Medical Rehabilitation and Balneotherapy
Minsk, , Belarus
Health Institution City Endocrinological Dispensary
Minsk, , Belarus
Belarusian Medical Academy of Postgraduate Education
Minsk, , Belarus
Health Institution Mogilev Diagnostic Center
Mogilev, , Belarus
LMC Endocrinology Centres
Calgary, Alberta, Canada
LMC Endocrinology Centres
Oakville, Ontario, Canada
LMC Endocrinoly Centres
Toronto, Ontario, Canada
Fakultni nemocnice Kralovske Vinohrady - II. internal department
Prague, , Czechia
IKEM/Diabetes Centre/Videnska
Prague, , Czechia
Tutkimusyksikko
Oulu, , Finland
DDZ Studienzentrum Deutsches Diabetes Zentrum
Düsseldorf, , Germany
Universitatsklinikum Giessen
Giessen, , Germany
Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult
Hanover, , Germany
Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
München, , Germany
Institut für Diabetesforschung Münster GmbH
Münster, , Germany
University of Szeged Faculty of Medicin
Szeged, , Hungary
Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum
Veszprém, , Hungary
Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum
Zalaegerszeg, , Hungary
Diabetes Clinic Soroka University
Beersheba, , Israel
Soroka University Medical Center
Beersheba, , Israel
Rambam Medical Cent
Haifa, , Israel
Wolfson Medical Center
Holon, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Institute for Endocrinology and Diabetes Schneider Children's MC
Petach-Tiqva, , Israel
. Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm
Palermo, , Italy
Dept. of Endocrinology and Diabetes University Campus Bio-Medico
Rome, , Italy
University La Sapienza, Policlinico Umberto I
Rome, , Italy
Private Clinic JSC 'Kristavita'
Jonava, , Lithuania
Kaunas Medical University Hospital
Kaunas, , Lithuania
Public Institution 'Seskines Outpatient Clinic'
Vilnius, , Lithuania
Vilnius Medical University Hospital, Santariskiu Clinic's
Vilnius, , Lithuania
NZOZ OmniMed
Lodz, , Poland
State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical
Chelyabinsk, , Russia
Kemerovo Regional Clinical Hospital
Kemerovo, , Russia
Endocrinological scientific center of Rosmedtechnology
Moscow, , Russia
SEIAPE Endocrinology and Diabetology
Moscow, , Russia
City Clinical Hospital #81, Endocrinology Department
Moscow, , Russia
Clinic of New Medical Technology, LLC
Moscow, , Russia
State Healthcare Institution (SHI) "Nizhegorodskaya
Nizhny Novgorod, , Russia
State Healthcare Institution Perm Region Clinical Hospital
Perm, , Russia
St. Petersburg State Healthcare Institution
Saint Petersburg, , Russia
State Educational Institution of Higher Professional Education
Saint Petersburg, , Russia
Limited Liability Company (LLC), Diabetes Center
Samara, , Russia
Siberian State Medical University of Roszdrav
Tomsk, , Russia
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Countries
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References
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Huurman VA, van der Meide PE, Duinkerken G, Willemen S, Cohen IR, Elias D, Roep BO. Immunological efficacy of heat shock protein 60 peptide DiaPep277 therapy in clinical type I diabetes. Clin Exp Immunol. 2008 Jun;152(3):488-97. doi: 10.1111/j.1365-2249.2008.03656.x. Epub 2008 Apr 16.
Huurman VA, Decochez K, Mathieu C, Cohen IR, Roep BO. Therapy with the hsp60 peptide DiaPep277 in C-peptide positive type 1 diabetes patients. Diabetes Metab Res Rev. 2007 May;23(4):269-75. doi: 10.1002/dmrr.691.
Schloot NC, Meierhoff G, Lengyel C, Vandorfi G, Takacs J, Panczel P, Barkai L, Madacsy L, Oroszlan T, Kovacs P, Suto G, Battelino T, Hosszufalusi N, Jermendy G. Effect of heat shock protein peptide DiaPep277 on beta-cell function in paediatric and adult patients with recent-onset diabetes mellitus type 1: two prospective, randomized, double-blind phase II trials. Diabetes Metab Res Rev. 2007 May;23(4):276-85. doi: 10.1002/dmrr.707.
Raz I, Avron A, Tamir M, Metzger M, Symer L, Eldor R, Cohen IR, Elias D. Treatment of new-onset type 1 diabetes with peptide DiaPep277 is safe and associated with preserved beta-cell function: extension of a randomized, double-blind, phase II trial. Diabetes Metab Res Rev. 2007 May;23(4):292-8. doi: 10.1002/dmrr.712.
Eldor R, Kassem S, Raz I. Immune modulation in type 1 diabetes mellitus using DiaPep277: a short review and update of recent clinical trial results. Diabetes Metab Res Rev. 2009 May;25(4):316-20. doi: 10.1002/dmrr.942.
Raz I, Elias D, Avron A, Tamir M, Metzger M, Cohen IR. Beta-cell function in new-onset type 1 diabetes and immunomodulation with a heat-shock protein peptide (DiaPep277): a randomised, double-blind, phase II trial. Lancet. 2001 Nov 24;358(9295):1749-53. doi: 10.1016/S0140-6736(01)06801-5.
Elias D, Avron A, Tamir M, Raz I. DiaPep277 preserves endogenous insulin production by immunomodulation in type 1 diabetes. Ann N Y Acad Sci. 2006 Oct;1079:340-4. doi: 10.1196/annals.1375.052.
Nussbaum G, Zanin-Zhorov A, Quintana F, Lider O, Cohen IR. Peptide p277 of HSP60 signals T cells: inhibition of inflammatory chemotaxis. Int Immunol. 2006 Oct;18(10):1413-9. doi: 10.1093/intimm/dxl074. Epub 2006 Aug 7.
Fischer B, Elias D, Bretzel RG, Linn T. Immunomodulation with heat shock protein DiaPep277 to preserve beta cell function in type 1 diabetes - an update. Expert Opin Biol Ther. 2010 Feb;10(2):265-72. doi: 10.1517/14712590903555176.
Other Identifiers
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DiaPep277-1001
Identifier Type: -
Identifier Source: org_study_id
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