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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F14%3A33149272" target="_blank" >RIV/61989592:15110/14:33149272 - isvavai.cz</a>

Výsledek na webu

<a href="http://care.diabetesjournals.org/content/37/5/1392.long" target="_blank" >http://care.diabetesjournals.org/content/37/5/1392.long</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.2337/dc13-1391" target="_blank" >10.2337/dc13-1391</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

OBJECTIVE: To evaluate safety and efficacy of DiaPep277 in preserving beta-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-groupclinical 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 HbA1c ?7% (?53 mmol/mol). Partial remission (target HbA1c 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 treat

Název v anglickém jazyce

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

Popis výsledku anglicky

OBJECTIVE: To evaluate safety and efficacy of DiaPep277 in preserving beta-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-groupclinical 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 HbA1c ?7% (?53 mmol/mol). Partial remission (target HbA1c 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 treat

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FB - Endokrinologie, diabetologie, metabolismus, výživa

OECD FORD obor

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Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2014

Kód důvěrnosti údajů

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

Název periodika

Diabetes Care

ISSN

0149-5992

e-ISSN

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Svazek periodika

37

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

1392-1400

Kód UT WoS článku

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EID výsledku v databázi Scopus

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