No Effect of the Altered Peptide Ligand NBI-6024 on beta-Cell Residual Function and Insulin Needs in New-Onset Type 1 Diabetes

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F09%3AN0000002" target="_blank" >RIV/00064173:_____/09:N0000002 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.2337/dc09-0449" target="_blank" >http://dx.doi.org/10.2337/dc09-0449</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.2337/dc09-0449" target="_blank" >10.2337/dc09-0449</a>

Result language

angličtina

Original language name

No Effect of the Altered Peptide Ligand NBI-6024 on beta-Cell Residual Function and Insulin Needs in New-Onset Type 1 Diabetes

Original language description

OBJECTIVE: This randomized, four-arm, placebo-controlled, dose-ranging phase 2 trial was conducted to determine whether repeated subcutaneous injections of the altered peptide ligand, NBI-6024, designed to inhibit autoreactive T-cells, improves beta-cell function in patients with recently diagnosed type 1 diabetes. RESEARCH DESIGN AND METHODS: A total of 188 patients, aged 10-35 years, with recently diagnosed type 1 diabetes were randomly assigned for a treatment consisting of the subcutaneous administration of placebo or 1, 0.5, or 0.1 mg NBI-6024 at baseline, weeks 2 and 4, and then monthly until month 24. Fasting, peak, and area under the curve (AUC) C-peptide concentrations during a 2-h mixed-meal tolerance test were measured at 3-month intervals during treatment. Immune function parameters (islet antibodies and CD4 and CD8 T-cells) were also studied. RESULTS: The mean peak C-peptide concentration at 24 months after study entry showed no significant difference between the groups treated with 0.1 mg (0.59 pmol/ml), 0.5 mg (0.57 pmol/ml), and 1.0 mg NBI-6024 (0.48 pmol/ml) and the placebo group (0.54 pmol/ml). Fasting, stimulated peak, and AUC C-peptide concentrations declined linearly in all groups by approximately 60% over the 24-month treatment period. The average daily insulin needs at month 24 were also comparable between the four groups. No treatment-related changes in islet antibodies and T cell numbers were observed. CONCLUSIONS: Treatment with altered peptide ligand NBI-6024 at repeated doses of 0.1, 0.5, or 1.0 mg did not improve or maintain beta-cell function.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FG - Paediatrics

OECD FORD branch

—

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2009

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Diabetes Care

ISSN

0149-5992

e-ISSN

—

Volume of the periodical

32

Issue of the periodical within the volume

11

Country of publishing house

US - UNITED STATES

Number of pages

5

Pages from-to

2036-2040

UT code for WoS article

000271682800017

EID of the result in the Scopus database

2-s2.0-70449412682