Treatment of recent-onset type 1 diabetic patients with DiaPep277: Results of a double-blind, placebo-controlled, randomized phase 3 trial

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

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVE: To evaluate safety and efficacy of DiaPep277 in preserving β-cell function in type 1 diabetic patients. RESEARCH DESIGN AND METHODS: DIA-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. RESULTS: DiaPep277 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%). CONCLUSIONS: DiaPep277 safely contributes to preservation of β-cell function and to improved glycemic control in patients with type 1 diabetes.

Original languageEnglish
Pages (from-to)1392-1400
Number of pages9
JournalDiabetes Care
Volume37
Issue number5
DOIs
StatePublished - May 2014
Externally publishedYes

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