Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults (DIA-AID2)

This study is currently recruiting participants.

Verified September 2011 by Andromeda Biotech Ltd.

Sponsor:

Information provided by (Responsible Party):

Andromeda Biotech Ltd.

ClinicalTrials.gov Identifier:

NCT01103284

First received: April 13, 2010

Last updated: September 14, 2011

Last verified: September 2011

History of Changes

Purpose

This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells.

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.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus	Drug: DiaPep277 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Further study details as provided by Andromeda Biotech Ltd.:

Primary Outcome Measures:

beta-cell function, measured as change from baseline in stimulated C-peptide secretion (AUC) during a mixed-meal tolerance test [ Time Frame: 25 months after 1st administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent of subjects that achieve good glycemic control: HbA1c<7% [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	450
Study Start Date:	April 2010
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DiaPep277	Drug: DiaPep277 1.0 mg dose, administered as subcutaneous injection. Dosing schedule: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months Drug: Placebo 40 mg mannitol, administered subcutaneously, Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

clinical diagnosis of type 1 diabetes within last 6 months
Age 20-45 years
fasting basal C-peptide equal or greater than 0.22nmol/L, lower than 0.8nmol/L
BMI between 17 and 30 at screening

Exclusion Criteria:

Significant disease or condition other than type 1 diabetes
Diabetes-related complications
Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103284

Contacts

Contact: Merana Tamir, Ph.D.

+972 8 9387730

merana@andromedabio.com

Hide Study Locations

Locations

United States, California
	Recruiting
Los Gatos, California, United States, 95032
Contact 408 358 2663 mailto:cherlinsoffice@msn.com
Principal Investigator: Richard Cherlin, MD
Sutter Gold Medical Foundation	Recruiting
Modesto, California, United States, 95355
Contact: Stephanie Edmonson, BS, CCRC 209-521-6097 ext 3492 edmonsons@sutterhealth.org
Principal Investigator: Celina Hetnal, MD
San Diego Clinical Trials	Recruiting
San Diego, California, United States, 92120
Contact: Brian Hamblen, CCRC 619-287-6000 BrianHamblen@sdclinicaltrials.com
Principal Investigator: Gerard Bazille, MD
United States, Colorado
University of Colorado Hospital - Anschutz Outpatient Pavilion	Recruiting
Aurora, Colorado, United States, 80045
Contact: Jennifer Tryggestad 720-848-2692 Jennifer.Tryggestad@UCDenver.edu
Principal Investigator: Michael McDermott, MD
Creekside Endocrine Associates, Inc.	Recruiting
Denver, Colorado, United States, 80209
Contact: Leonard Zemel, MD 303-388-6410 zennylemel@aol.com
Principal Investigator: Leonard Zemel, MD
United States, District of Columbia
George Washington University Medical Faculty Associates	Recruiting
Washington, District of Columbia, United States, 20037
Contact: Carol Wingfield, RN 202-741-2442 cwingfield@mfa.gwu.edu
Principal Investigator: Joshua Cohen, MD
United States, Florida
Innovative Medical Research of South Florida Inc.	Recruiting
Aventura, Florida, United States, 33180
Contact: Tracey Sackel 305-759-1881 Innmedtraceys@aol.com
Principal Investigator: Carlos Coelho, MD
	Recruiting
DeLand, Florida, United States, 32720
Contact 386-738-1731 blancolunamd@aol.com
Principal Investigator: Blanca Luna, MD
Orlando Diabetes & Endocrine Specialists, P.A.	Recruiting
Orlando, Florida, United States, 32825
Contact 407-293-2150 drkb@bestendo.com
Principal Investigator: Kimberly Bourne, MD
Tallahassee Endocrine Associates	Recruiting
Tallahassee, Florida, United States, 32308
Contact: Charlotte Sanborn, LPN 850-877-7387 ext 107 tlhendocrine@yahoo.com
Principal Investigator: Terry W Sherraden, MD
Diabetes and Hormonal Disease Center	Recruiting
Tampa, Florida, United States, 33613
Contact: Brooke Reale 813-977-2020 brookrdhdcresearch@yahoo.com
Principal Investigator: Yuvrai Kumbkarni, MD
United States, Georgia
Atlanta Diabetes Associates	Recruiting
Atlanta, Georgia, United States, 30309
Contact 404-355-4393 bbode001@aol.com
Principal Investigator: Bruce Bode, MD
United States, Kentucky
Kentucky Diabetes Endocrinology Center	Recruiting
Lexington, Kentucky, United States, 40503
Contact 859-977-2472 wmiers@kyde.com
Principal Investigator: Wendell Miers, MD
United States, Missouri
Washington University	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Carol Recklein, RN, CDE 314-362-8608 creckle@dom.wustl.edu
Principal Investigator: Janet McGill, MD
United States, Nevada
Palm Medical Research Center	Recruiting
Las Vegas, Nevada, United States, 89148
Contact 702-736-5161 samernakhle@yahoo.com
Principal Investigator: Samer Nakhle, MD
United States, New Mexico
Soutwest Clinical Research Center, LLC	Recruiting
Santa Fe, New Mexico, United States, 87505
Contact: Lisa Kaufman 505-699-5697 lisak.crc@gmail.com
Principal Investigator: Robert Bernstein, MD, FACE
United States, North Carolina
Mountain Diabetes and Endocrine Center	Recruiting
Ashville, North Carolina, United States, 28803
Contact 828-258-2404 mountaindiabetes@msn.com
Principal Investigator: Wendy Lane, MD
University of North Carolina Diabetes Care Center	Recruiting
Durham, North Carolina, United States, 27703
Contact: Michelle Duclos, MPH, CCRC 919-484-0931 ext 270 michelle_duclos@med.unc.edu
Principal Investigator: John Buse, MD
United States, Ohio
The Lindner Research Center, The Christ Hospital	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Dean Kereiakes, MD 513-585-1777 lindnermd@thechristhospital.com
Principal Investigator: Dean Kereiakes, MD
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Robert McCoy, RN 216-445-4029 Mccoyr@ccf.org
Principal Investigator: Leann Olansky, MD
United States, Oregon
Legacy Clinical Research & Technology Center	Recruiting
Portland, Oregon, United States, 97210
Contact: Susan Staat 503-413-8330 sstaat@lhs.org
Principal Investigator: Scott Grady, MD
United States, Tennessee
AM Diabetes & Endocrinology Center	Recruiting
Bartlett, Tennessee, United States, 38133
Contact: Laura Beth Smith, RN 901-531-6236 laurabeth@researchrn.com
Principal Investigator: Kashif Latif, MD
United States, Texas
Research Institute of Dallas	Recruiting
Dallas, Texas, United States, 75231
Contact: Terry Dunnam 214-265-2145 tdunnam@researchdallas.com
Principal Investigator: Stephen Aronoff, MD
Cetero Research	Recruiting
San Antonio, Texas, United States, 78229
Contact: Donna Baldwin 210-426-3777 ext 6884 donna.baldwin@cetero.com
Principal Investigator: Jolene Berg, MD
United States, Washington
Northside Internal Medicine Associates, PS	Recruiting
Spokane, Washington, United States, 99208
Contact 509-489-7483 hcathcart@columbiamedicalassociates.com
Principal Investigator: Harold Cathcart, MD
Multicare Specialties Research	Recruiting
Tacoma, Washington, United States, 98405
Contact: Shannon Harris 253-301-6990 shannon.harris@multicare.com
Principal Investigator: Ronald Graf, MD
Austria
Universitatsklinik fur Innere Medzin I, Landeskrankenhaus	Recruiting
Innsbruck, Austria, 6020
Contact: Claudia Ress 512 504 81402 claudia.ress@i-med.ac.at
Principal Investigator: Christoph Ebenbichler, MD
Rudolfstiftung Hospital	Recruiting
Vienna, Austria, 1030
Contact: Johanna Brix 1 711652135 johanna.brix@chello.at
Principal Investigator: Gunthram Schernthaner, MD
Belarus
Belarusian Medical Academy of Postgraduate Education	Recruiting
Minsk, Belarus, 220096
Contact 17 340-57-22-12-00 larisa.dan@gmail.com
Principal Investigator: Larisa Ivanovna Danilova, MD
Health Institution City Endocrinological Dispensary	Recruiting
Minsk, Belarus, 220029
Contact 17 2881239 ikhorad@rambler.ru
Principal Investigator: Nataliya Viktorovna Karlovich, MD
Republican center of Medical Rehabilitation and Balneotherapy	Recruiting
Minsk, Belarus, 220013
Contact 17 263-97-69 drhelen@yandex.ru
Principal Investigator: Elena Ivanovna Kuzmenkova, MD
Endocrinological Unit 1st City Clinical Hospital	Recruiting
Minsk, Belarus, 220013
Contact: Dyagileva Oksana, MD 17 331-92-58 ikhorad@rambler.ru
Principal Investigator: Nataliya Mikhailovna Likhorad, MD
Health Institution Mogilev Diagnostic Center	Recruiting
Mogilov, Belarus, 212030
Contact 17 263-97-69 Selivanov4@mail.ru
Principal Investigator: Vladimir Nikolaevich Selivanov, MD
Canada, Alberta
LMC Endocrinology Centres	Recruiting
Calgary, Alberta, Canada, T2H 0K2
Contact: Belinda Bender 403-288-3225 belinda.bender@lmc.ca
Principal Investigator: Stuart Ross, MB, CH.B
Canada, Ontario
LMC Endocrinology Centres	Recruiting
Oakville, Ontario, Canada, L6H 3P1
Contact: Winnie Ku, BScH, CCRC 905-337-0040 ext 35 winnie.ku@lmc.ca
Principal Investigator: David Twum-Barima, MD
LMC Endocrinoly Centres	Recruiting
Toronto, Ontario, Canada, M4R 2G4
Contact: Tanya Levin 416-789-9188 ext 225 Tanya.levin@LMC.CA
Principal Investigator: Ronnie Aronson, MD
Czech Republic
IKEM/Diabetes Centre/Videnska	Recruiting
Prague, Czech Republic, 4140
Contact: Dagmar Kövešlygetyová +420 26136 4140 dakv@medicon.cz
Principal Investigator: Terezia Pelikanova, MD
Fakultni nemocnice Kralovske Vinohrady - II. internal department	Recruiting
Prague, Czech Republic, 10035
Contact: Elena Silhova, MD +420 296 473 454 Elena.Silhova@seznam.cz
Principal Investigator: Michal Andel, MD
Finland
Tutkimusyksikko	Recruiting
Oulu, Finland, 90220
Contact: Mia Jylha + 358 40 1760970 mia.jylha@oulu.fi
Principal Investigator: Riitta Antikainen, MD
Germany
DDZ Studienzentrum Deutsches Diabetes Zentrum	Recruiting
Dusseldorf, Germany, 40225
Contact: Petra Heidkamp 0211 3382 209 studienzentrum@ddz.uniduesseldorf.de
Principal Investigator: Nannette Schloot, MD
Universitatsklinikum Giessen	Recruiting
Giessen, Germany, 35392
Contact: Jutta Sitte, RN +49-641-99-42787 Jutta.Sitte@innere.med.uni-giessen.de
Principal Investigator: Thomas Linn, MD
Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult	Recruiting
Hannover, Germany, 30173
Contact: Erika Marquardt 0511 8115 3336 diabetesstudie@hka.de
Principal Investigator: Thomas Danne, MD
Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin	Recruiting
Munchen, Germany, 80804
Contact: Melanie Bunk 089-3068-5574 Melanie.Bunk@lrz.uni-muenchen.de
Principal Investigator: Annette G Ziegler, MD
Institut für Diabetesforschung Münster GmbH	Recruiting
Munster, Germany, 48145
Contact: Sina Hüneburg 0251 935 2321 diabetesforschung@diabetes-muenster.de
Principal Investigator: Dirk Lammers, MD
Hungary
University of Szeged Faculty of Medicin	Recruiting
Szeged, Hungary, H-6700
Contact 062- 545186 lecs@in1st.szote.u-szeged.hu
Principal Investigator: Csabal Lengyel, md
Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum	Recruiting
Veszprem, Hungary, 8200
Contact 088 406 354 huvandorfi@upcmail.hu
Principal Investigator: Gyozo Vandorfi, MD
Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum	Recruiting
Zalaegerszeg, Hungary, 9000
Contact 092 507 527 oroszlan.bel@zmkorhaz.hu
Principal Investigator: Tamas Oroszlan, MD
Israel
Diabetes Clinic Soroka University	Recruiting
Beer Sheva, Israel, 84101
Contact: Sagit Saadon 08-6477368 gonda@bgu.ac.il
Principal Investigator: Ilana Harman-Boehm, MD
Soroka University Medical Center	Recruiting
Beer Sheva, Israel, 84101
Contact: Tali Binder +972- (0)8-6477368 bindert@bgu.ac.il
Principal Investigator: Ilana Harman-Boehm, MD
Rambam Medical Cent	Recruiting
Haifa, Israel, 31096
Contact: Daniel Katz +972-4-8542646 DaKatz@rambam.health.gov.il
Principal Investigator: Naim Shehadeh, MD
Wolfson Medical Center	Recruiting
Holon, Israel
Contact: Ganz Tali 03-5028392 tali_phd@walla.co.il
Principal Investigator: Julio Wainstein, MD
Sub-Investigator: Zohar Landau, MD
Hadassah Medical Center	Recruiting
Jerusalem, Israel
Contact: Esther Butbul 02-6777473 beti@hadassah.org.il
Principal Investigator: Itamar Raz, MD
Institute for Endocrinology and Diabetes Schneider Children's MC	Recruiting
Petach-Tiqva, Israel, 49202
Contact: Alona Hamou 03-9253850 alonah@clalit.org.il
Principal Investigator: Liat de Vries, MD
Italy
. Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm	Recruiting
Palermo, Italy, 90127
Contact: Alessandro Ciresi 091 6552 109 a.ciresi@virgilio.it
Principal Investigator: Carla Giordano, MD
Dept. of Endocrinology and Diabetes University Campus Bio-Medico	Recruiting
Rome, Italy, 00128
Contact: Luciana Valente 06 22541 781 l.valente@unicampus.it
Principal Investigator: Paolo Pozzilli, MD
University La Sapienza, Policlinico Umberto I	Recruiting
Rome, Italy, 00161
Contact: Ilaria Barchetta, MD +39 06 49974692 I.Barchetta@unicampus.it
Principal Investigator: Gisella Cavallo, MD
Lithuania
Private Clinic JSC 'Kristavita'	Recruiting
Jonava, Lithuania, 55201
Contact: Kristina Aglinskiene, MD +37 06 50 95 396 kristinaaglinskiene@yahoo.com
Principal Investigator: Kristina Aglinskiene, MD
Sub-Investigator: Neringa Martinoniene, MD
Kaunas Medical University Hospital	Recruiting
Kaunas, Lithuania, 50009
Contact: Rita Sulcaite, MD +37037326142 ritasulc@takas.lt
Principal Investigator: Rita Sulcaite, MD
Sub-Investigator: Lina Barsiene, MD
Vilnius Medical University Hospital, Santariskiu Clinic's	Recruiting
Vilnius, Lithuania, 08661
Contact: Rasa Juskiene, MD +37 06 86 84 788 rasa.juskiene@santa.lt
Principal Investigator: Rasa Juskiene, MD
Sub-Investigator: Rasa Ziukaite, MD
Sub-Investigator: Romena Laukiene, MD
Public Institution 'Seskines Outpatient Clinic'	Recruiting
Vilnius, Lithuania, 07156
Contact: Ilona Lapteva, MD +37 06 98 32 060 adolfaarmalyte@gmail.com
Principal Investigator: Ilona Lapteva, MD
Sub-Investigator: Vida Pupininkiene, MD
Poland
NZOZ OmniMed	Recruiting
Lodz, Poland, 93-338
Contact: Marcin Kosinski, MD +48 422711153 cosa@mp.pl
Principal Investigator: Katarzyna Cypryk, MD/Prof
Sub-Investigator: Joanna Grycewicz, MD
Russian Federation
State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical	Recruiting
Chelyabinsk, Russian Federation, 454021
Contact: Sergey Levashov, MD +8 3517412173 levashovs@mail.ru
Principal Investigator: Emilia Volkova, MD
Sub-Investigator: Svetlana Ponomareva, MD
Kemerovo Regional Clinical Hospital	Recruiting
Kemerovo, Russian Federation, 650066
Contact: Ekaterina Chernyavskaya, MD + 7 3842 52 1474 cheku2@mail.ru
Principal Investigator: Olga Barbarash, MD
Sub-Investigator: Olga Golinskaya, MD
SEIAPE Endocrinology and Diabetology	Recruiting
Moscow, Russian Federation, 125367
Contact: Natalia Chernikova, MD + 7 495 490 0114 endocrin@mtu-net.ru
Principal Investigator: Alexander Ametov, MD
Sub-Investigator: Irina Galenina, MD
City Clinical Hospital #81, Endocrinology Department	Recruiting
Moscow, Russian Federation, 127644
Contact: Anton Rogozin, MD +7 495 483 94 44 aragozin@mail.ru
Principal Investigator: Irina Demidova, MD
Sub-Investigator: Katevan Tsaguriya, MD
Clinic of New Medical Technology, LLC	Recruiting
Moscow, Russian Federation, 140091
Contact: Larisa Kalinina, MD +7 495 5441060 stellaka@yandex.ru
Principal Investigator: Albina Golovach, MD
Sub-Investigator: Irina Eremina, MD
Endocrinological scientific center of Rosmedtechnology	Recruiting
Moscow, Russian Federation, 117036
Contact: Vera Gorelysheva, MD +7 499 1266652 evrint@mail.ru
Principal Investigator: Olga Smirnova, MD
Sub-Investigator: Tatiana Nikinova, MD
State Healthcare Institution (SHI) "Nizhegorodskaya	Recruiting
Nizhni Novgorod, Russian Federation, 603126
Contact: Vladimir Nosov, MD +7 831 245 32 26 klub2006@yahoo.com
Principal Investigator: Galina Varvarina, MD
Sub-Investigator: Svetlana Zhuk, MD
State Healthcare Institution Perm Region Clinical Hospital	Recruiting
Perm, Russian Federation, 614990
Contact: Tatiana Medina, MD + 7 342 239 30 70 tgmedina@yandex.ru
Principal Investigator: Elena Smirnova, MD
Sub-Investigator: Klara Malaniena, MD
Limited Liability Company (LLC), Diabetes Center	Recruiting
Samara, Russian Federation, 443067
Contact: Maria Verbovaya, MD +88462621854 mverbovaya@rambler.ru
Principal Investigator: Nelly Verbovaya, MD
Sub-Investigator: Tatiana Suldina, MD
State Educational Institution of Higher Professional Education	Recruiting
St Petersburg, Russian Federation, 197022
Contact: Tatiana Karonova, MD +7 812 234 54 81 karonova@mail.ru
Principal Investigator: Elena Krasilnikova, MD
Sub-Investigator: Anna Bystrova, MD
St. Petersburg State Healthcare Institution	Recruiting
St. Petersburg, Russian Federation, 194354
Contact: Elena Ostrovskaya, MD + 88122963102 iakar@mail.ru
Principal Investigator: Irina Karpova, MD
Siberian State Medical University of Roszdrav	Recruiting
Tomsk, Russian Federation, 634050
Contact: Oksana Oleynik, MD +8 3822530127 oleynikoa@mail.ru
Principal Investigator: Julia Samoylova, MD
Sub-Investigator: Anastasiya Enert, MD
Spain
Complejo Hospitalario Universitario Insular Materno-Infantil	Recruiting
Las Palmas de Gran Canaria, Spain, 35016
Contact: Jose Ignacio Aide +34 928 441617 joseaide@hotmail.com
Contact: Lucia Martin Ojeda lmartinojeda@gmail.com
Principal Investigator: Ana Maria Wagner, MD
Hospital Universitari Arnau de Vilanova	Recruiting
Lleida, Spain, 25198
Contact: Nuria Garcia, MD + 34 973 70 52 40 nurieta82@gmail.com
Principal Investigator: Marta Hernandez Garcia, MD
Sub-Investigator: Mauricio Didac, MD

Sponsors and Collaborators

Andromeda Biotech Ltd.

Investigators

Principal Investigator:	Itamar Raz, MD	Hadassah Medical Center, Jerusalem
Principal Investigator:	Thomas Linn, MD	Justus-Liebig University, Giessen
Principal Investigator:	Paolo P Pozzilli, MB, BS, MD	University Campus Bio-Medico, Rome
Principal Investigator:	Philip Raskin, MD	UT Southwestern Medical Center, Dallas

More Information

Additional Information:

the Sponsor site, with specific information on DiaPep277 mode of action This link exits the ClinicalTrials.gov site

Publications:

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. 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.

Schloot NC, Meierhoff G, Lengyel C, Vándorfi G, Takács J, Pánczél P, Barkai L, Madácsy L, Oroszlán T, Kovács P, Sütö 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.

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.

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. Review.

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.

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.

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. 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. Review.

Responsible Party:	Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:	NCT01103284 History of Changes
Other Study ID Numbers:	DiaPep277-1001
Study First Received:	April 13, 2010
Last Updated:	September 14, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Israel: Ethics Commission

Keywords provided by Andromeda Biotech Ltd.:

beta-cells
autoimmune
Diabetes
immunomodulation

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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