Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults - Full Text View

Sponsor:	Andromeda Biotech Ltd.
Information provided by (Responsible Party):	Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:	NCT01103284

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 III

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: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: DiaPep 277

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

Show 75 Study Locations

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 February 21, 2012