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Sponsored by: |
Andromeda Biotech Ltd. |
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Information provided by: | Andromeda Biotech Ltd. |
ClinicalTrials.gov Identifier: | NCT00615264 |
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.
Condition | Intervention | Phase |
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Type 1 Diabetes |
Drug: DiaPep277 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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 Patients |
Estimated Enrollment: | 400 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
DiaPep277 1.0 mg + 40 mg Mannitol in 0.5ml lipid emulsion
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Drug: DiaPep277
1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
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2: Placebo Comparator
Mannitol 40 mg in 0.5ml lipid emulsion
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Drug: Placebo
Mannitol 40 mg in 0.5ml lipid emulsion
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Ages Eligible for Study: | 16 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Merana Tamir, Ph.D. | +972 8 9387730 | merana@andromedabio.com |
Principal Investigator: | Itamar Raz, MD | Hadassah Medical Center, Jerusalem |
Principal Investigator: | Paolo Pozzilli, MD | Universita Campus Bio-Medico, Rome |
Principal Investigator: | Francois Bonici, MD | New Groote Schuur Hospital, Cape Town |
Principal Investigator: | Thomas Linn, MD | Universitätsklinikum, Giessen |
Responsible Party: | Andromeda Biotech Ltd. ( Dana Elias, Program Director ) |
Study ID Numbers: | 901, ISRCTN55429664 |
Study First Received: | February 4, 2008 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00615264 |
Health Authority: | Austria: Federal Ministry for Health and Women; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Israel: The Israel National Institute for Health Policy Research and Health Services Research; Italy: Ministry of Health; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Mannitol Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |