Treatment of Recent-Onset Type 1 Diabetic Patients With DiaPep277: Results of a Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial.

Carla Giordano, Ann Avron, Dana Peled, Dana Elias, Merana Tamir, Irun R. Cohen, Julio Wainstein, Rachel Eren, Larry A. Distiller, Shlomo Dagan, Francois Bonnici, Didac Mauricio, Itamar Raz, Vlastimil Procházka, Francesco Giorgino, Thomas Linn, Guntram Schernthaner, Paolo Pozzilli, Liat De Vries, Anette G. ZieglerIrun R. Cohen

Risultato della ricerca: Articlepeer review

34 Citazioni (Scopus)

Abstract

OBJECTIVETo evaluate safety and efficacy of DiaPep277 in preserving -cell function in type 1 diabetic patients.RESEARCH DESIGN AND METHODSDIA-AID 1 is a multinational, phase 3, balanced-randomized, double-blind, placebo-controlled, parallel-group clinical study. Newly diagnosed patients (N = 457, aged 16-45 years) were randomized to subcutaneous injections of DiaPep277 or placebo quarterly for 2 years. The primary efficacy end point was the change from baseline in the area under the glucagon-stimulated C-peptide curve. Secondary end points were the change from baseline in mixed-meal stimulated C-peptide secretion and in fasting C-peptide and achieving target HbA(1c) 7% (53 mmol/mol). Partial remission (target HbA(1c) on insulin 0.5 units/kg/day) and hypoglycemic event rate were exploratory end points.RESULTSDiaPep277 was safe and well tolerated. Significant preservation of C-peptide secretion was observed in the DiaPep277-treated group compared with the placebo (relative treatment effects of 23.4%, P = 0.037, and 29.2%, P = 0.011, in the modified intent-to-treat [mITT] and per-protocol [PP] populations, respectively). The mixed-meal stimulation failed to distinguish between the groups. There was a trend toward efficacy in fasting C-peptide levels, though not statistically significant. Significantly more DiaPep277-treated than placebo-treated patients maintained target HbA(1c) (mITT 56% versus 44%, P = 0.03; PP 60% versus 45%, P = 0.0082) and entered partial remission (mITT 38% versus 29%, P = 0.08; PP 42% versus 30%, P = 0.035). DiaPep277 treatment reduced the relative hypoglycemic event risk (mITT by 20%; PP by 28%).CONCLUSIONSDiaPep277 safely contributes to preservation of -cell function and to improved glycemic control in patients with type 1 diabetes.
Lingua originaleEnglish
pagine (da-a)1392-1400
Numero di pagine9
RivistaDiabetes Care
Volume37
Stato di pubblicazionePublished - 2014

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialised Nursing

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