Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults

Type 1 Diabetes Mellitus Clinical Trial

— DIA-AID2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01103284
• Other study ID #: DiaPep277-1001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 13, 2010
• Last updated: July 10, 2013
• Start date: April 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2013
• Source: Andromeda Biotech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaIsrael: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Austria	Universitatsklinik fur Innere Medzin I, Landeskrankenhaus	Innsbruck
Austria	Rudolfstiftung Hospital	Vienna
Belarus	Belarusian Medical Academy of Postgraduate Education	Minsk
Belarus	Endocrinological Unit 1st City Clinical Hospital	Minsk
Belarus	Health Institution City Endocrinological Dispensary	Minsk
Belarus	Republican center of Medical Rehabilitation and Balneotherapy	Minsk
Belarus	Health Institution Mogilev Diagnostic Center	Mogilov
Canada	LMC Endocrinology Centres	Calgary	Alberta
Canada	LMC Endocrinology Centres	Oakville	Ontario
Canada	LMC Endocrinoly Centres	Toronto	Ontario
Czech Republic	Fakultni nemocnice Kralovske Vinohrady - II. internal department	Prague
Czech Republic	IKEM/Diabetes Centre/Videnska	Prague
Finland	Tutkimusyksikko	Oulu
Germany	DDZ Studienzentrum Deutsches Diabetes Zentrum	Dusseldorf
Germany	Universitatsklinikum Giessen	Giessen
Germany	Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult	Hannover
Germany	Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin	Munchen
Germany	Institut für Diabetesforschung Münster GmbH	Munster
Hungary	University of Szeged Faculty of Medicin	Szeged
Hungary	Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum	Veszprem
Hungary	Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum	Zalaegerszeg
Israel	Diabetes Clinic Soroka University	Beer Sheva
Israel	Soroka University Medical Center	Beer Sheva
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
Italy	. 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
Lithuania	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
Poland	NZOZ OmniMed	Lodz
Russian Federation	State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical	Chelyabinsk
Russian Federation	Kemerovo Regional Clinical Hospital	Kemerovo
Russian Federation	City Clinical Hospital #81, Endocrinology Department	Moscow
Russian Federation	Clinic of New Medical Technology, LLC	Moscow
Russian Federation	Endocrinological scientific center of Rosmedtechnology	Moscow
Russian Federation	SEIAPE Endocrinology and Diabetology	Moscow
Russian Federation	State Healthcare Institution (SHI) "Nizhegorodskaya	Nizhni Novgorod
Russian Federation	State Healthcare Institution Perm Region Clinical Hospital	Perm
Russian Federation	Limited Liability Company (LLC), Diabetes Center	Samara
Russian Federation	State Educational Institution of Higher Professional Education	St Petersburg
Russian Federation	St. Petersburg State Healthcare Institution	St. Petersburg
Russian Federation	Siberian State Medical University of Roszdrav	Tomsk
Spain	Complejo Hospitalario Universitario Insular Materno-Infantil	Las Palmas de Gran Canaria
Spain	Hospital Universitari Arnau de Vilanova	Lleida
United States	Mountain Diabetes and Endocrine Center	Ashville	North Carolina
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	University of Colorado Hospital - Anschutz Outpatient Pavilion	Aurora	Colorado
United States	Innovative Medical Research of South Florida Inc.	Aventura	Florida
United States	AM Diabetes & Endocrinology Center	Bartlett	Tennessee
United States	The Lindner Research Center, The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Research Institute of Dallas	Dallas	Texas
United States	Creekside Endocrine Associates, Inc.	Denver	Colorado
United States	University of North Carolina Diabetes Care Center	Durham	North Carolina
United States	Palm Medical Research Center	Las Vegas	Nevada
United States	Kentucky Diabetes Endocrinology Center	Lexington	Kentucky
United States	Sutter Gold Medical Foundation	Modesto	California
United States	Orlando Diabetes & Endocrine Specialists, P.A.	Orlando	Florida
United States	Legacy Clinical Research & Technology Center	Portland	Oregon
United States	Cetero Research	San Antonio	Texas
United States	San Diego Clinical Trials	San Diego	California
United States	Soutwest Clinical Research Center, LLC	Santa Fe	New Mexico
United States	Northside Internal Medicine Associates, PS	Spokane	Washington
United States	Washington University	St. Louis	Missouri
United States	Multicare Specialties Research	Tacoma	Washington
United States	Tallahassee Endocrine Associates	Tallahassee	Florida
United States	Diabetes and Hormonal Disease Center	Tampa	Florida
United States	George Washington University Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Andromeda Biotech Ltd.

Countries where clinical trial is conducted

United States,  Austria,  Belarus,  Canada,  Czech Republic,  Finland,  Germany,  Hungary,  Israel,  Italy,  Lithuania,  Poland,  Russian Federation,  Spain, 

References & Publications (9)

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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Epub 2006 Aug 7. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	daily insulin dose, adjusted to body weight (IU/kg)		25 months	No
Other	frequency of hypoglycemic events		25 months	Yes
Primary	beta-cell function, measured as change from baseline in stimulated C-peptide secretion (AUC) during a mixed-meal tolerance test		25 months after 1st administration	No
Secondary	Percent of subjects that achieve good glycemic control: HbA1c<7%		25 months	Yes