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
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
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.
Inclusion Criteria:
Exclusion Criteria:
Washington D.C., District of Columbia 20037, United States
Ashville, North Carolina 28803, United States
München, 80804, Germany
Veszprém, 8200, Hungary
Petach-Tiqva, 49202, Israel
Palermo, 90127, Italy
Chelyabinsk, 454021, Russia
Las Palmas de Gran Canaria, 35016, Spain