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Heat-shock protein peptide DiaPep277 treatment in children with newly diagnosed type 1 diabetes: a randomised,

L Lazar1, R Ofan, N Weintrob

  • 1The institute for Endocrinology and Diabetes, National Center of Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.

Diabetes/Metabolism Research and Reviews
|November 25, 2006
PubMed

Insights

DiaPep277 treatment is safe for children with recent-onset type 1 diabetes mellitus (T1DM). However, this peptide therapy did not preserve beta-cell function or improve metabolic control in the study.

Area of Science:

  • Immunology
  • Endocrinology
  • Pediatrics

Background:

  • Type 1 diabetes mellitus (T1DM) is an autoimmune disease targeting insulin-producing beta cells.
  • DiaPep277, a heat-shock protein 60 (hsp60) derived peptide, showed promise in slowing beta-cell function decline in prior studies.
  • Evaluating DiaPep277's efficacy in preserving beta-cell function in children with recent-onset T1DM is crucial.

Purpose of the Study:

  • To assess the efficacy and safety of DiaPep277 in children with recent-onset T1DM.
  • To determine if DiaPep277 can attenuate beta-cell destruction and improve metabolic control.
  • To evaluate long-term outcomes of DiaPep277 treatment in pediatric T1DM.

Main Methods:

  • Prospective, randomized, double-blind, phase II clinical trial.
  • 30 children (7-14 years) with recent-onset T1DM received 1 mg DiaPep277 or placebo (mannitol) via subcutaneous injection.
  • Follow-up was 18 months, comparing stimulated C-peptide, insulin dose, and HbA1c.

Main Results:

  • C-peptide levels decreased similarly in both DiaPep277 and placebo groups.
  • No significant differences were observed in insulin dose or HbA1c between treatment groups.
  • No serious drug-related adverse effects were reported during the study.

Conclusions:

  • One-year treatment with 1 mg DiaPep277 is safe and well-tolerated in children with recent-onset T1DM.
  • DiaPep277 did not demonstrate a beneficial effect on preserving beta-cell function.
  • The study found no improvement in metabolic control with DiaPep277 treatment in this pediatric population.
Abstract

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