Back to resultsEfficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults (DIA-AID2)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DiaPep277
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring beta-cells, autoimmune, Diabetes, immunomodulation
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
Sites / Locations
- Sutter Gold Medical Foundation
- San Diego Clinical Trials
- University of Colorado Hospital - Anschutz Outpatient Pavilion
- Creekside Endocrine Associates, Inc.
- George Washington University Medical Faculty Associates
- Innovative Medical Research of South Florida Inc.
- Orlando Diabetes & Endocrine Specialists, P.A.
- Tallahassee Endocrine Associates
- Diabetes and Hormonal Disease Center
- Atlanta Diabetes Associates
- Kentucky Diabetes Endocrinology Center
- Washington University
- Palm Medical Research Center
- Soutwest Clinical Research Center, LLC
- Mountain Diabetes and Endocrine Center
- University of North Carolina Diabetes Care Center
- The Lindner Research Center, The Christ Hospital
- Cleveland Clinic
- Legacy Clinical Research & Technology Center
- AM Diabetes & Endocrinology Center
- Research Institute of Dallas
- Cetero Research
- Northside Internal Medicine Associates, PS
- Multicare Specialties Research
- Universitatsklinik fur Innere Medzin I, Landeskrankenhaus
- Rudolfstiftung Hospital
- Endocrinological Unit 1st City Clinical Hospital
- Republican center of Medical Rehabilitation and Balneotherapy
- Health Institution City Endocrinological Dispensary
- Belarusian Medical Academy of Postgraduate Education
- Health Institution Mogilev Diagnostic Center
- LMC Endocrinology Centres
- LMC Endocrinology Centres
- LMC Endocrinoly Centres
- Fakultni nemocnice Kralovske Vinohrady - II. internal department
- IKEM/Diabetes Centre/Videnska
- Tutkimusyksikko
- DDZ Studienzentrum Deutsches Diabetes Zentrum
- Universitatsklinikum Giessen
- Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult
- Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
- Institut für Diabetesforschung Münster GmbH
- University of Szeged Faculty of Medicin
- Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum
- Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum
- Diabetes Clinic Soroka University
- Soroka University Medical Center
- Rambam Medical Cent
- Wolfson Medical Center
- Hadassah Medical Center
- Institute for Endocrinology and Diabetes Schneider Children's MC
- . Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm
- Dept. of Endocrinology and Diabetes University Campus Bio-Medico
- University La Sapienza, Policlinico Umberto I
- Private Clinic JSC 'Kristavita'
- Kaunas Medical University Hospital
- Public Institution 'Seskines Outpatient Clinic'
- Vilnius Medical University Hospital, Santariskiu Clinic's
- NZOZ OmniMed
- State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical
- Kemerovo Regional Clinical Hospital
- Endocrinological scientific center of Rosmedtechnology
- SEIAPE Endocrinology and Diabetology
- City Clinical Hospital #81, Endocrinology Department
- Clinic of New Medical Technology, LLC
- State Healthcare Institution (SHI) "Nizhegorodskaya
- State Healthcare Institution Perm Region Clinical Hospital
- Limited Liability Company (LLC), Diabetes Center
- State Educational Institution of Higher Professional Education
- St. Petersburg State Healthcare Institution
- Siberian State Medical University of Roszdrav
- Complejo Hospitalario Universitario Insular Materno-Infantil
- Hospital Universitari Arnau de Vilanova
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DiaPep277
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%
The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.
Frequency of Hypoglycemic Events
Total number of days with at least one hypoglycemic event recorded
Mean Number of Days With at Least One Hypoglycemic Event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01103284
Brief Title
Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
Acronym
DIA-AID2
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andromeda Biotech Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
beta-cells, autoimmune, Diabetes, immunomodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
475 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DiaPep277
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DiaPep277
Intervention Description
1.0 mg dose in 0.5 mL of solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
Primary Outcome Measure Information:
Title
Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months
Description
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.
Time Frame
Baseline and 24 months
Secondary Outcome Measure Information:
Title
Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%
Description
The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.
Time Frame
24 and 25 months
Title
Frequency of Hypoglycemic Events
Description
Total number of days with at least one hypoglycemic event recorded
Time Frame
Baseline to 25 Months
Title
Mean Number of Days With at Least One Hypoglycemic Event
Time Frame
Baseline to 25 months
Other Pre-specified Outcome Measures:
Title
Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study
Description
Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with a daily insulin dose ≤ 0.5 IU/kg at study end.
Time Frame
24 and 25 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itamar Raz, MD
Organizational Affiliation
Hadassah Medical Center, Jerusalem
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Linn, MD
Organizational Affiliation
University of Giessen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo P Pozzilli, MB, BS, MD
Organizational Affiliation
University Campus Bio-Medico, Rome
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip Raskin, MD
Organizational Affiliation
UT Southwestern Medical Center, Dallas
Official's Role
Principal Investigator
Facility Information:
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Sutter Gold Medical Foundation
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Outpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Creekside Endocrine Associates, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Innovative Medical Research of South Florida Inc.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Orlando Diabetes & Endocrine Specialists, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Tallahassee Endocrine Associates
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Diabetes and Hormonal Disease Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Kentucky Diabetes Endocrinology Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Palm Medical Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Soutwest Clinical Research Center, LLC
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Mountain Diabetes and Endocrine Center
City
Ashville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
University of North Carolina Diabetes Care Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
The Lindner Research Center, The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Legacy Clinical Research & Technology Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
AM Diabetes & Endocrinology Center
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Cetero Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Northside Internal Medicine Associates, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Multicare Specialties Research
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Universitatsklinik fur Innere Medzin I, Landeskrankenhaus
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Rudolfstiftung Hospital
City
Vienna
ZIP/Postal Code
1030
Country
Austria
Facility Name
Endocrinological Unit 1st City Clinical Hospital
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Republican center of Medical Rehabilitation and Balneotherapy
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Health Institution City Endocrinological Dispensary
City
Minsk
ZIP/Postal Code
220029
Country
Belarus
Facility Name
Belarusian Medical Academy of Postgraduate Education
City
Minsk
ZIP/Postal Code
220096
Country
Belarus
Facility Name
Health Institution Mogilev Diagnostic Center
City
Mogilov
ZIP/Postal Code
212030
Country
Belarus
Facility Name
LMC Endocrinology Centres
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 0K2
Country
Canada
Facility Name
LMC Endocrinology Centres
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
LMC Endocrinoly Centres
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4R 2G4
Country
Canada
Facility Name
Fakultni nemocnice Kralovske Vinohrady - II. internal department
City
Prague
ZIP/Postal Code
10035
Country
Czech Republic
Facility Name
IKEM/Diabetes Centre/Videnska
City
Prague
ZIP/Postal Code
4140
Country
Czech Republic
Facility Name
Tutkimusyksikko
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
DDZ Studienzentrum Deutsches Diabetes Zentrum
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitatsklinikum Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
City
Munchen
ZIP/Postal Code
80804
Country
Germany
Facility Name
Institut für Diabetesforschung Münster GmbH
City
Munster
ZIP/Postal Code
48145
Country
Germany
Facility Name
University of Szeged Faculty of Medicin
City
Szeged
ZIP/Postal Code
H-6700
Country
Hungary
Facility Name
Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum
City
Zalaegerszeg
ZIP/Postal Code
9000
Country
Hungary
Facility Name
Diabetes Clinic Soroka University
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Cent
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Institute for Endocrinology and Diabetes Schneider Children's MC
City
Petach-Tiqva
ZIP/Postal Code
49202
Country
Israel
Facility Name
. Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Dept. of Endocrinology and Diabetes University Campus Bio-Medico
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
University La Sapienza, Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Private Clinic JSC 'Kristavita'
City
Jonava
ZIP/Postal Code
55201
Country
Lithuania
Facility Name
Kaunas Medical University Hospital
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Public Institution 'Seskines Outpatient Clinic'
City
Vilnius
ZIP/Postal Code
07156
Country
Lithuania
Facility Name
Vilnius Medical University Hospital, Santariskiu Clinic's
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
NZOZ OmniMed
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical
City
Chelyabinsk
ZIP/Postal Code
454021
Country
Russian Federation
Facility Name
Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Endocrinological scientific center of Rosmedtechnology
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
SEIAPE Endocrinology and Diabetology
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
City Clinical Hospital #81, Endocrinology Department
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Clinic of New Medical Technology, LLC
City
Moscow
ZIP/Postal Code
140091
Country
Russian Federation
Facility Name
State Healthcare Institution (SHI) "Nizhegorodskaya
City
Nizhni Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
State Healthcare Institution Perm Region Clinical Hospital
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Limited Liability Company (LLC), Diabetes Center
City
Samara
ZIP/Postal Code
443067
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Siberian State Medical University of Roszdrav
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Complejo Hospitalario Universitario Insular Materno-Infantil
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
18422727
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.
Results Reference
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PubMed Identifier
17024692
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.
Results Reference
background
PubMed Identifier
17103487
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.
Results Reference
background
PubMed Identifier
17124720
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.
Results Reference
background
PubMed Identifier
19267355
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.
Results Reference
background
PubMed Identifier
11734230
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.
Results Reference
background
PubMed Identifier
17130576
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.
Results Reference
background
PubMed Identifier
16893923
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
background
Learn more about this trial
Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
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