Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults (DIA-AID2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT01103284
First received: April 13, 2010
Last updated: July 10, 2013
Last verified: July 2013
  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 3

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:


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 ]

Other Outcome Measures:
  • daily insulin dose, adjusted to body weight (IU/kg) [ Time Frame: 25 months ] [ Designated as safety issue: No ]
  • frequency of hypoglycemic events [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103284

  Hide Study Locations
Locations
United States, California
Los Gatos, California, United States, 95032
Sutter Gold Medical Foundation
Modesto, California, United States, 95355
San Diego Clinical Trials
San Diego, California, United States, 92120
United States, Colorado
University of Colorado Hospital - Anschutz Outpatient Pavilion
Aurora, Colorado, United States, 80045
Creekside Endocrine Associates, Inc.
Denver, Colorado, United States, 80209
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Florida
Innovative Medical Research of South Florida Inc.
Aventura, Florida, United States, 33180
DeLand, Florida, United States, 32720
Orlando Diabetes & Endocrine Specialists, P.A.
Orlando, Florida, United States, 32825
Tallahassee Endocrine Associates
Tallahassee, Florida, United States, 32308
Diabetes and Hormonal Disease Center
Tampa, Florida, United States, 33613
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
United States, Kentucky
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States, 40503
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Nevada
Palm Medical Research Center
Las Vegas, Nevada, United States, 89148
United States, New Mexico
Soutwest Clinical Research Center, LLC
Santa Fe, New Mexico, United States, 87505
United States, North Carolina
Mountain Diabetes and Endocrine Center
Ashville, North Carolina, United States, 28803
University of North Carolina Diabetes Care Center
Durham, North Carolina, United States, 27703
United States, Ohio
The Lindner Research Center, The Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Legacy Clinical Research & Technology Center
Portland, Oregon, United States, 97210
United States, Tennessee
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, United States, 38133
United States, Texas
Research Institute of Dallas
Dallas, Texas, United States, 75231
Cetero Research
San Antonio, Texas, United States, 78229
United States, Washington
Northside Internal Medicine Associates, PS
Spokane, Washington, United States, 99208
Multicare Specialties Research
Tacoma, Washington, United States, 98405
Austria
Universitatsklinik fur Innere Medzin I, Landeskrankenhaus
Innsbruck, Austria, 6020
Rudolfstiftung Hospital
Vienna, Austria, 1030
Belarus
Belarusian Medical Academy of Postgraduate Education
Minsk, Belarus, 220096
Health Institution City Endocrinological Dispensary
Minsk, Belarus, 220029
Republican center of Medical Rehabilitation and Balneotherapy
Minsk, Belarus, 220013
Endocrinological Unit 1st City Clinical Hospital
Minsk, Belarus, 220013
Health Institution Mogilev Diagnostic Center
Mogilov, Belarus, 212030
Canada, Alberta
LMC Endocrinology Centres
Calgary, Alberta, Canada, T2H 0K2
Canada, Ontario
LMC Endocrinology Centres
Oakville, Ontario, Canada, L6H 3P1
LMC Endocrinoly Centres
Toronto, Ontario, Canada, M4R 2G4
Czech Republic
IKEM/Diabetes Centre/Videnska
Prague, Czech Republic, 4140
Fakultni nemocnice Kralovske Vinohrady - II. internal department
Prague, Czech Republic, 10035
Finland
Tutkimusyksikko
Oulu, Finland, 90220
Germany
DDZ Studienzentrum Deutsches Diabetes Zentrum
Dusseldorf, Germany, 40225
Universitatsklinikum Giessen
Giessen, Germany, 35392
Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult
Hannover, Germany, 30173
Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
Munchen, Germany, 80804
Institut für Diabetesforschung Münster GmbH
Munster, Germany, 48145
Hungary
University of Szeged Faculty of Medicin
Szeged, Hungary, H-6700
Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum
Veszprem, Hungary, 8200
Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum
Zalaegerszeg, Hungary, 9000
Israel
Diabetes Clinic Soroka University
Beer Sheva, Israel, 84101
Soroka University Medical Center
Beer Sheva, Israel, 84101
Rambam Medical Cent
Haifa, Israel, 31096
Wolfson Medical Center
Holon, Israel
Hadassah Medical Center
Jerusalem, Israel
Institute for Endocrinology and Diabetes Schneider Children's MC
Petach-Tiqva, Israel, 49202
Italy
. Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm
Palermo, Italy, 90127
Dept. of Endocrinology and Diabetes University Campus Bio-Medico
Rome, Italy, 00128
University La Sapienza, Policlinico Umberto I
Rome, Italy, 00161
Lithuania
Private Clinic JSC 'Kristavita'
Jonava, Lithuania, 55201
Kaunas Medical University Hospital
Kaunas, Lithuania, 50009
Vilnius Medical University Hospital, Santariskiu Clinic's
Vilnius, Lithuania, 08661
Public Institution 'Seskines Outpatient Clinic'
Vilnius, Lithuania, 07156
Poland
NZOZ OmniMed
Lodz, Poland, 93-338
Russian Federation
State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical
Chelyabinsk, Russian Federation, 454021
Kemerovo Regional Clinical Hospital
Kemerovo, Russian Federation, 650066
SEIAPE Endocrinology and Diabetology
Moscow, Russian Federation, 125367
City Clinical Hospital #81, Endocrinology Department
Moscow, Russian Federation, 127644
Clinic of New Medical Technology, LLC
Moscow, Russian Federation, 140091
Endocrinological scientific center of Rosmedtechnology
Moscow, Russian Federation, 117036
State Healthcare Institution (SHI) "Nizhegorodskaya
Nizhni Novgorod, Russian Federation, 603126
State Healthcare Institution Perm Region Clinical Hospital
Perm, Russian Federation, 614990
Limited Liability Company (LLC), Diabetes Center
Samara, Russian Federation, 443067
State Educational Institution of Higher Professional Education
St Petersburg, Russian Federation, 197022
St. Petersburg State Healthcare Institution
St. Petersburg, Russian Federation, 194354
Siberian State Medical University of Roszdrav
Tomsk, Russian Federation, 634050
Spain
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, Spain, 35016
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
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:
Publications:

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: July 10, 2013
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 August 28, 2014