Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
- Registration Number
- NCT01103284
- Lead Sponsor
- Andromeda Biotech Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 475
- 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
- Significant disease or condition other than type 1 diabetes
- Diabetes-related complications
- Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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. DiaPep277 DiaPep277 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months Baseline and 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
Name Time Method Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7% 24 and 25 months 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 Baseline to 25 Months Total number of days with at least one hypoglycemic event recorded
Mean Number of Days With at Least One Hypoglycemic Event Baseline to 25 months
Trial Locations
- Locations (72)
AM Diabetes & Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
Sutter Gold Medical Foundation
🇺🇸Modesto, California, United States
San Diego Clinical Trials
🇺🇸San Diego, California, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion
🇺🇸Aurora, Colorado, United States
Creekside Endocrine Associates, Inc.
🇺🇸Denver, Colorado, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Innovative Medical Research of South Florida Inc.
🇺🇸Aventura, Florida, United States
Orlando Diabetes & Endocrine Specialists, P.A.
🇺🇸Orlando, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Kentucky Diabetes Endocrinology Center
🇺🇸Lexington, Kentucky, United States
Tallahassee Endocrine Associates
🇺🇸Tallahassee, Florida, United States
Diabetes and Hormonal Disease Center
🇺🇸Tampa, Florida, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Soutwest Clinical Research Center, LLC
🇺🇸Santa Fe, New Mexico, United States
Mountain Diabetes and Endocrine Center
🇺🇸Ashville, North Carolina, United States
University of North Carolina Diabetes Care Center
🇺🇸Durham, North Carolina, United States
Cetero Research
🇺🇸San Antonio, Texas, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Multicare Specialties Research
🇺🇸Tacoma, Washington, United States
Northside Internal Medicine Associates, PS
🇺🇸Spokane, Washington, United States
Endocrinological Unit 1st City Clinical Hospital
🇧🇾Minsk, Belarus
Health Institution City Endocrinological Dispensary
🇧🇾Minsk, Belarus
Health Institution Mogilev Diagnostic Center
🇧🇾Mogilov, Belarus
LMC Endocrinoly Centres
🇨🇦Toronto, Ontario, Canada
LMC Endocrinology Centres
🇨🇦Oakville, Ontario, Canada
IKEM/Diabetes Centre/Videnska
🇨🇿Prague, Czech Republic
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, Germany
Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum
🇭🇺Veszprem, Hungary
Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum
🇭🇺Zalaegerszeg, Hungary
Diabetes Clinic Soroka University
🇮🇱Beer Sheva, Israel
Wolfson Medical Center
🇮🇱Holon, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Institute for Endocrinology and Diabetes Schneider Children's MC
🇮🇱Petach-Tiqva, Israel
Private Clinic JSC 'Kristavita'
🇱🇹Jonava, Lithuania
. 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
Kaunas Medical University Hospital
🇱🇹Kaunas, Lithuania
NZOZ OmniMed
🇵🇱Lodz, Poland
State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical
🇷🇺Chelyabinsk, Russian Federation
Kemerovo Regional Clinical Hospital
🇷🇺Kemerovo, 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 Educational Institution of Higher Professional Education
🇷🇺St Petersburg, Russian Federation
Siberian State Medical University of Roszdrav
🇷🇺Tomsk, Russian Federation
Complejo Hospitalario Universitario Insular Materno-Infantil
🇪🇸Las Palmas de Gran Canaria, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Palm Medical Research Center
🇺🇸Las Vegas, Nevada, United States
Universitatsklinik fur Innere Medzin I, Landeskrankenhaus
🇦🇹Innsbruck, Austria
Rudolfstiftung Hospital
🇦🇹Vienna, Austria
Republican center of Medical Rehabilitation and Balneotherapy
🇧🇾Minsk, Belarus
Belarusian Medical Academy of Postgraduate Education
🇧🇾Minsk, Belarus
Fakultni nemocnice Kralovske Vinohrady - II. internal department
🇨🇿Prague, Czech Republic
Tutkimusyksikko
🇫🇮Oulu, Finland
Vilnius Medical University Hospital, Santariskiu Clinic's
🇱🇹Vilnius, Lithuania
University of Szeged Faculty of Medicin
🇭🇺Szeged, Hungary
Soroka University Medical Center
🇮🇱Beer Sheva, Israel
Rambam Medical Cent
🇮🇱Haifa, Israel
Public Institution 'Seskines Outpatient Clinic'
🇱🇹Vilnius, Lithuania
State Healthcare Institution Perm Region Clinical Hospital
🇷🇺Perm, Russian Federation
Limited Liability Company (LLC), Diabetes Center
🇷🇺Samara, Russian Federation
Clinic of New Medical Technology, LLC
🇷🇺Moscow, Russian Federation
City Clinical Hospital #81, Endocrinology Department
🇷🇺Moscow, Russian Federation
St. Petersburg State Healthcare Institution
🇷🇺St. Petersburg, Russian Federation
University La Sapienza, Policlinico Umberto I
🇮🇹Rome, Italy
The Lindner Research Center, The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Legacy Clinical Research & Technology Center
🇺🇸Portland, Oregon, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States