Clinical trial NCT01103284: Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
Official title: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical Efficacy and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: beta-cells
autoimmune
Diabetes
immunomodulation
Lead sponsor: Andromeda Biotech Ltd.
Sponsor class: INDUSTRY
First posted: 2010-04-14
Enrollment: 475
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 0.22 nmol/L, lower than 0.8 nmol/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

Primary outcomes:
measure: Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%
timeFrame: 24 and 25 months
measure: Frequency of Hypoglycemic Events
timeFrame: Baseline to 25 Months
measure: Mean Number of Days With at Least One Hypoglycemic Event
timeFrame: Baseline to 25 months
Other outcomes:
measure: Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study
timeFrame: 24 and 25 months
Locations:
city: Los Gatos
country: United States
state: California
city: Modesto
country: United States
facility: Sutter Gold Medical Foundation
state: California
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Outpatient Pavilion
state: Colorado
city: Denver
country: United States
facility: Creekside Endocrine Associates, Inc.
state: Colorado
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida Inc.
state: Florida
city: DeLand
country: United States
state: Florida
city: Orlando
country: United States
facility: Orlando Diabetes & Endocrine Specialists, P.A.
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Endocrine Associates
state: Florida
city: Tampa
country: United States
facility: Diabetes and Hormonal Disease Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Lexington
country: United States
facility: Kentucky Diabetes Endocrinology Center
state: Kentucky
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Palm Medical Research Center
state: Nevada
city: Santa Fe
country: United States
facility: Soutwest Clinical Research Center, LLC
state: New Mexico
city: Ashville
country: United States
facility: Mountain Diabetes and Endocrine Center
state: North Carolina
city: Durham
country: United States
facility: University of North Carolina Diabetes Care Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center, The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Legacy Clinical Research & Technology Center
state: Oregon
city: Bartlett
country: United States
facility: AM Diabetes & Endocrinology Center
state: Tennessee
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
city: Spokane
country: United States
facility: Northside Internal Medicine Associates, PS
state: Washington
city: Tacoma
country: United States
facility: Multicare Specialties Research
state: Washington
city: Innsbruck
country: Austria
facility: Universitatsklinik fur Innere Medzin I, Landeskrankenhaus
city: Vienna
country: Austria
facility: Rudolfstiftung Hospital
city: Minsk
country: Belarus
facility: Endocrinological Unit 1st City Clinical Hospital
city: Minsk
country: Belarus
facility: Republican center of Medical Rehabilitation and Balneotherapy
city: Minsk
country: Belarus
facility: Health Institution City Endocrinological Dispensary
city: Minsk
country: Belarus
facility: Belarusian Medical Academy of Postgraduate Education
city: Mogilov
country: Belarus
facility: Health Institution Mogilev Diagnostic Center
city: Calgary
country: Canada
facility: LMC Endocrinology Centres
state: Alberta
city: Oakville
country: Canada
facility: LMC Endocrinology Centres
state: Ontario
city: Toronto
country: Canada
facility: LMC Endocrinoly Centres
state: Ontario
city: Prague
country: Czech Republic
facility: Fakultni nemocnice Kralovske Vinohrady - II. internal department
city: Prague
country: Czech Republic
facility: IKEM/Diabetes Centre/Videnska
city: Oulu
country: Finland
facility: Tutkimusyksikko
city: Dusseldorf
country: Germany
facility: DDZ Studienzentrum Deutsches Diabetes Zentrum
city: Giessen
country: Germany
facility: Universitatsklinikum Giessen
city: Hannover
country: Germany
facility: Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult
city: Munchen
country: Germany
facility: Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
city: Munster
country: Germany
facility: Institut für Diabetesforschung Münster GmbH
city: Szeged
country: Hungary
facility: University of Szeged Faculty of Medicin
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum
city: Beer Sheva
country: Israel
facility: Diabetes Clinic Soroka University
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Cent
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petach-Tiqva
country: Israel
facility: Institute for Endocrinology and Diabetes Schneider Children's MC
city: Palermo
country: Italy
facility: . Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm
city: Rome
country: Italy
facility: Dept. of Endocrinology and Diabetes University Campus Bio-Medico
city: Rome
country: Italy
facility: University La Sapienza, Policlinico Umberto I
city: Jonava
country: Lithuania
facility: Private Clinic JSC 'Kristavita'
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital
city: Vilnius
country: Lithuania
facility: Public Institution 'Seskines Outpatient Clinic'
city: Vilnius
country: Lithuania
facility: Vilnius Medical University Hospital, Santariskiu Clinic's
city: Lodz
country: Poland
facility: NZOZ OmniMed
city: Chelyabinsk
country: Russian Federation
facility: State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Endocrinological scientific center of Rosmedtechnology
city: Moscow
country: Russian Federation
facility: SEIAPE Endocrinology and Diabetology
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #81, Endocrinology Department
city: Moscow
country: Russian Federation
facility: Clinic of New Medical Technology, LLC
city: Nizhni Novgorod
country: Russian Federation
facility: State Healthcare Institution (SHI) "Nizhegorodskaya
city: Perm
country: Russian Federation
facility: State Healthcare Institution Perm Region Clinical Hospital
city: Samara
country: Russian Federation
facility: Limited Liability Company (LLC), Diabetes Center
city: St Petersburg
country: Russian Federation
facility: State Educational Institution of Higher Professional Education
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University of Roszdrav
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno-Infantil
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
Study officials:
affiliation: Hadassah Medical Center, Jerusalem
name: Itamar Raz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Giessen
name: Thomas Linn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Campus Bio-Medico, Rome
name: Paolo P Pozzilli, MB, BS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center, Dallas
name: Philip Raskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.