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Etanercept Treatment in Children With New-Onset Type 1 Diabetes: Pilot randomized, placebo-controlled, double-blind study
OBJECTIVE: To gather preliminary data on the feasibility and efficacy of etanercept therapy to prolong endogenous insulin production in pediatric patients with newly diagnosed type 1 diabetes. RESEARCH DESIGN AND METHODS: This was a 24-week double-blind, randomized, placebo-controlled study conducte...
Autores principales: | , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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American Diabetes Association
2009
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699714/ https://www.ncbi.nlm.nih.gov/pubmed/19366957 http://dx.doi.org/10.2337/dc09-0054 |
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author | Mastrandrea, Lucy Yu, Jihnhee Behrens, Torsten Buchlis, John Albini, Christine Fourtner, Shannon Quattrin, Teresa |
author_facet | Mastrandrea, Lucy Yu, Jihnhee Behrens, Torsten Buchlis, John Albini, Christine Fourtner, Shannon Quattrin, Teresa |
author_sort | Mastrandrea, Lucy |
collection | PubMed |
description | OBJECTIVE: To gather preliminary data on the feasibility and efficacy of etanercept therapy to prolong endogenous insulin production in pediatric patients with newly diagnosed type 1 diabetes. RESEARCH DESIGN AND METHODS: This was a 24-week double-blind, randomized, placebo-controlled study conducted at the Diabetes Center, Women and Children's Hospital of Buffalo. Eighteen subjects (11 male and 7 female, aged 7.8–18.2 years) were randomly assigned to receive either placebo or etanercept. Inclusion criteria included age 3–18 years, GAD-65 and/or islet cell antibody positivity, A1C >6%, three insulin injections per day, white blood cell count 3,000–10,000, platelets >100,000, and normal liver and renal function. Intention-to-treat analysis was used. RESULTS: A1C at week 24 was lower in the etanercept group (5.91 ± 0.5%) compared with that in the placebo group (6.98 ± 1.2%; P < 0.05) with a higher percent decrease from baseline than in the placebo group (etanercept 0.41 ± 0.1 vs. placebo 0.18 ± 0.21; P < 0.01). The percent change in C-peptide area under the curve from baseline to week 24 showed a 39% increase in the etanercept group and a 20% decrease in the placebo group (P < 0.05). From baseline to week 24 insulin dose decreased 18% in the etanercept group compared with a 23% increase in the placebo group (P < 0.05). Seventeen patients completed the study, and none withdrew because of adverse events. CONCLUSIONS: In this small pilot study, treatment of pediatric patients newly diagnosed with type 1 diabetes with etanercept resulted in lower A1C and increased endogenous insulin production, suggesting preservation of β-cell function. A larger study is needed to further explore safety and efficacy. |
format | Text |
id | pubmed-2699714 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2009 |
publisher | American Diabetes Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-26997142010-07-01 Etanercept Treatment in Children With New-Onset Type 1 Diabetes: Pilot randomized, placebo-controlled, double-blind study Mastrandrea, Lucy Yu, Jihnhee Behrens, Torsten Buchlis, John Albini, Christine Fourtner, Shannon Quattrin, Teresa Diabetes Care Original Research OBJECTIVE: To gather preliminary data on the feasibility and efficacy of etanercept therapy to prolong endogenous insulin production in pediatric patients with newly diagnosed type 1 diabetes. RESEARCH DESIGN AND METHODS: This was a 24-week double-blind, randomized, placebo-controlled study conducted at the Diabetes Center, Women and Children's Hospital of Buffalo. Eighteen subjects (11 male and 7 female, aged 7.8–18.2 years) were randomly assigned to receive either placebo or etanercept. Inclusion criteria included age 3–18 years, GAD-65 and/or islet cell antibody positivity, A1C >6%, three insulin injections per day, white blood cell count 3,000–10,000, platelets >100,000, and normal liver and renal function. Intention-to-treat analysis was used. RESULTS: A1C at week 24 was lower in the etanercept group (5.91 ± 0.5%) compared with that in the placebo group (6.98 ± 1.2%; P < 0.05) with a higher percent decrease from baseline than in the placebo group (etanercept 0.41 ± 0.1 vs. placebo 0.18 ± 0.21; P < 0.01). The percent change in C-peptide area under the curve from baseline to week 24 showed a 39% increase in the etanercept group and a 20% decrease in the placebo group (P < 0.05). From baseline to week 24 insulin dose decreased 18% in the etanercept group compared with a 23% increase in the placebo group (P < 0.05). Seventeen patients completed the study, and none withdrew because of adverse events. CONCLUSIONS: In this small pilot study, treatment of pediatric patients newly diagnosed with type 1 diabetes with etanercept resulted in lower A1C and increased endogenous insulin production, suggesting preservation of β-cell function. A larger study is needed to further explore safety and efficacy. American Diabetes Association 2009-07 2009-04-14 /pmc/articles/PMC2699714/ /pubmed/19366957 http://dx.doi.org/10.2337/dc09-0054 Text en © 2009 by the American Diabetes Association. https://creativecommons.org/licenses/by-nc-nd/3.0/Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ (https://creativecommons.org/licenses/by-nc-nd/3.0/) for details. |
spellingShingle | Original Research Mastrandrea, Lucy Yu, Jihnhee Behrens, Torsten Buchlis, John Albini, Christine Fourtner, Shannon Quattrin, Teresa Etanercept Treatment in Children With New-Onset Type 1 Diabetes: Pilot randomized, placebo-controlled, double-blind study |
title | Etanercept Treatment in Children With New-Onset Type 1 Diabetes: Pilot randomized, placebo-controlled, double-blind study |
title_full | Etanercept Treatment in Children With New-Onset Type 1 Diabetes: Pilot randomized, placebo-controlled, double-blind study |
title_fullStr | Etanercept Treatment in Children With New-Onset Type 1 Diabetes: Pilot randomized, placebo-controlled, double-blind study |
title_full_unstemmed | Etanercept Treatment in Children With New-Onset Type 1 Diabetes: Pilot randomized, placebo-controlled, double-blind study |
title_short | Etanercept Treatment in Children With New-Onset Type 1 Diabetes: Pilot randomized, placebo-controlled, double-blind study |
title_sort | etanercept treatment in children with new-onset type 1 diabetes: pilot randomized, placebo-controlled, double-blind study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699714/ https://www.ncbi.nlm.nih.gov/pubmed/19366957 http://dx.doi.org/10.2337/dc09-0054 |
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