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

NCT01103284 | Completed Phase 3 Results DMC

• 1 other identifier: DiaPep277-1001
• Study Type: interventional
• Target: 475
• Locations: 14 countries
• Sites: 75

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

beta-cells; autoimmune; Diabetes; immunomodulation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months

  Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration \[area under the curve (AUC), 0-20 minutes\] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.

  Baseline and 24 months

Secondary Outcomes (3)

• Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%

  24 and 25 months

• Frequency of Hypoglycemic Events

  Baseline to 25 Months

• Mean Number of Days With at Least One Hypoglycemic Event

  Baseline to 25 months

Other Outcomes (1)

• Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study

  24 and 25 months

Study Arms (2)

DiaPep277

EXPERIMENTAL

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.

Drug: DiaPep277

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

DiaPep277 DRUG

1.0 mg dose in 0.5 mL of solution

DiaPep277

Placebo DRUG

40 mg mannitol in 0.5 mL of solution. Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Andromeda Biotech Ltd.: lead

Study Sites (75)

Unknown Facility

Los Gatos, California, 95032, United States

Location

Sutter Gold Medical Foundation

Modesto, California, 95355, United States

Location

San Diego Clinical Trials

San Diego, California, 92120, United States

Location

University of Colorado Hospital - Anschutz Outpatient Pavilion

Aurora, Colorado, 80045, United States

Location

Creekside Endocrine Associates, Inc.

Denver, Colorado, 80209, United States

Location

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Innovative Medical Research of South Florida Inc.

Aventura, Florida, 33180, United States

Location

Unknown Facility

DeLand, Florida, 32720, United States

Location

Orlando Diabetes & Endocrine Specialists, P.A.

Orlando, Florida, 32825, United States

Location

Tallahassee Endocrine Associates

Tallahassee, Florida, 32308, United States

Location

Diabetes and Hormonal Disease Center

Tampa, Florida, 33613, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30309, United States

Location

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, 40503, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Palm Medical Research Center

Las Vegas, Nevada, 89148, United States

Location

Soutwest Clinical Research Center, LLC

Santa Fe, New Mexico, 87505, United States

Location

Mountain Diabetes and Endocrine Center

Ashville, North Carolina, 28803, United States

Location

University of North Carolina Diabetes Care Center

Durham, North Carolina, 27703, United States

Location

The Lindner Research Center, The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Legacy Clinical Research & Technology Center

Portland, Oregon, 97210, United States

Location

AM Diabetes & Endocrinology Center

Bartlett, Tennessee, 38133, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Cetero Research

San Antonio, Texas, 78229, United States

Location

Northside Internal Medicine Associates, PS

Spokane, Washington, 99208, United States

Location

Multicare Specialties Research

Tacoma, Washington, 98405, United States

Location

Universitatsklinik fur Innere Medzin I, Landeskrankenhaus

Innsbruck, 6020, Austria

Location

Rudolfstiftung Hospital

Vienna, 1030, Austria

Location

Endocrinological Unit 1st City Clinical Hospital

Minsk, 220013, Belarus

Location

Republican center of Medical Rehabilitation and Balneotherapy

Minsk, 220013, Belarus

Location

Health Institution City Endocrinological Dispensary

Minsk, 220029, Belarus

Location

Belarusian Medical Academy of Postgraduate Education

Minsk, 220096, Belarus

Location

Health Institution Mogilev Diagnostic Center

Mogilev, 212030, Belarus

Location

LMC Endocrinology Centres

Calgary, Alberta, T2H 0K2, Canada

Location

LMC Endocrinology Centres

Oakville, Ontario, L6H 3P1, Canada

Location

LMC Endocrinoly Centres

Toronto, Ontario, M4R 2G4, Canada

Location

Fakultni nemocnice Kralovske Vinohrady - II. internal department

Prague, 10035, Czechia

Location

IKEM/Diabetes Centre/Videnska

Prague, 4140, Czechia

Location

Tutkimusyksikko

Oulu, 90220, Finland

Location

DDZ Studienzentrum Deutsches Diabetes Zentrum

Düsseldorf, 40225, Germany

Location

Universitatsklinikum Giessen

Giessen, 35392, Germany

Location

Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult

Hanover, 30173, Germany

Location

Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin

München, 80804, Germany

Location

Institut für Diabetesforschung Münster GmbH

Münster, 48145, Germany

Location

University of Szeged Faculty of Medicin

Szeged, H-6700, Hungary

Location

Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum

Veszprém, 8200, Hungary

Location

Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum

Zalaegerszeg, 9000, Hungary

Location

Diabetes Clinic Soroka University

Beersheba, 84101, Israel

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Rambam Medical Cent

Haifa, 31096, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Institute for Endocrinology and Diabetes Schneider Children's MC

Petach-Tiqva, 49202, Israel

Location

. Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm

Palermo, 90127, Italy

Location

Dept. of Endocrinology and Diabetes University Campus Bio-Medico

Rome, 00128, Italy

Location

University La Sapienza, Policlinico Umberto I

Rome, 00161, Italy

Location

Private Clinic JSC 'Kristavita'

Jonava, 55201, Lithuania

Location

Kaunas Medical University Hospital

Kaunas, 50009, Lithuania

Location

Public Institution 'Seskines Outpatient Clinic'

Vilnius, 07156, Lithuania

Location

Vilnius Medical University Hospital, Santariskiu Clinic's

Vilnius, 08661, Lithuania

Location

NZOZ OmniMed

Lodz, 93-338, Poland

Location

State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical

Chelyabinsk, 454021, Russia

Location

Kemerovo Regional Clinical Hospital

Kemerovo, 650066, Russia

Location

Endocrinological scientific center of Rosmedtechnology

Moscow, 117036, Russia

Location

SEIAPE Endocrinology and Diabetology

Moscow, 125367, Russia

Location

City Clinical Hospital #81, Endocrinology Department

Moscow, 127644, Russia

Location

Clinic of New Medical Technology, LLC

Moscow, 140091, Russia

Location

State Healthcare Institution (SHI) "Nizhegorodskaya

Nizhny Novgorod, 603126, Russia

Location

State Healthcare Institution Perm Region Clinical Hospital

Perm, 614990, Russia

Location

St. Petersburg State Healthcare Institution

Saint Petersburg, 194354, Russia

Location

State Educational Institution of Higher Professional Education

Saint Petersburg, 197022, Russia

Location

Limited Liability Company (LLC), Diabetes Center

Samara, 443067, Russia

Location

Siberian State Medical University of Roszdrav

Tomsk, 634050, Russia

Location

Complejo Hospitalario Universitario Insular Materno-Infantil

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Related Publications (9)

• 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.

  PMID: 18422727 BACKGROUND

• 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.

  PMID: 17024692 BACKGROUND

• 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.

  PMID: 17103487 BACKGROUND

• 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.

  PMID: 17124720 BACKGROUND

• 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.

  PMID: 19267355 BACKGROUND

• 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.

  PMID: 11734230 BACKGROUND

• 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.

  PMID: 17130576 BACKGROUND

• 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.

  PMID: 16893923 BACKGROUND

• 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.

  PMID: 20034363 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Jeanne Novak
• Organization: CBR International

jnovak@cbrintl.com

7207461190

Study Officials

• Itamar Raz, MD

  Hadassah Medical Center, Jerusalem

  PRINCIPAL INVESTIGATOR

• Thomas Linn, MD

  University of Giessen

  PRINCIPAL INVESTIGATOR

• Paolo P Pozzilli, MB, BS, MD

  University Campus Bio-Medico, Rome

  PRINCIPAL INVESTIGATOR

• Philip Raskin, MD

  UT Southwestern Medical Center, Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 14, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

LI (4); AU (2); RU (12); US (26); IL (6); ES (2); CZ (2); FI (1); IT (3); BE (5); CA (3); DE (5); PL (1); HU (3)