Intralymphatic GAD-alum (Diamyd (R)) improves glycemic control in type 1 diabetes with HLA DR3-DQ2

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F22%3A00083447" target="_blank" >RIV/00023001:_____/22:00083447 - isvavai.cz</a>

Result on the web

<a href="https://academic.oup.com/jcem/article/107/9/2644/6602344?login=true" target="_blank" >https://academic.oup.com/jcem/article/107/9/2644/6602344?login=true</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1210/clinem/dgac343" target="_blank" >10.1210/clinem/dgac343</a>

Result language

angličtina

Original language name

Intralymphatic GAD-alum (Diamyd (R)) improves glycemic control in type 1 diabetes with HLA DR3-DQ2

Original language description

Aims Residual beta cell function in type 1 diabetes (T1D) is associated with lower risk of complications. Autoantigen therapy with GAD-alum (Diamyd) given in 3 intralymphatic injections with oral vitamin D has shown promising results in persons with T1D carrying the human leukocyte antigen (HLA) DR3-DQ2 haplotype in the phase 2b trial DIAGNODE-2. We aimed to explore the efficacy of intralymphatic GAD-alum on blood glucose recorded by continuous glucose monitoring (CGM). Methods DIAGNODE-2 (NCT03345004) was a multicenter, randomized, placebo-controlled, double-blind trial of 109 recent-onset T1D patients aged 12 to 24 years with GAD65 antibodies and fasting C-peptide &gt; 0.12 nmol/L, which randomized patients to 3 intralymphatic injections of 4 mu g GAD-alum and oral vitamin D, or placebo. We report results for exploratory endpoints assessed by 14-day CGM at months 0, 6, and 15. Treatment arms were compared by mixed-effects models for repeated measures adjusting for baseline values. Results We included 98 patients with CGM recordings of sufficient quality (DR3-DQ2-positive patients: 27 GAD-alum-treated and 15 placebo-treated). In DR3-DQ2-positive patients, percent of time in range (TIR, 3.9-10 mmol/L) declined less between baseline and month 15 in GAD-alum-treated compared with placebo-treated patients (-5.1% and -16.7%, respectively; P = 0.0075), with reduced time &gt; 13.9 mmol/L (P = 0.0036), and significant benefits on the glucose management indicator (P = 0.0025). No differences were detected for hypoglycemia. GAD-alum compared to placebo lowered the increase in glycemic variability (standard deviation) observed in both groups (P = 0.0219). Change in C-peptide was correlated with the change in TIR. Conclusions Intralymphatic GAD-alum improves glycemic control in recently diagnosed T1D patients carrying HLA DR3-DQ2.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30202 - Endocrinology and metabolism (including diabetes, hormones)

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2022

Confidentiality

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

Name of the periodical

Journal of clinical endocrinology and metabolism

ISSN

0021-972X

e-ISSN

1945-7197

Volume of the periodical

107

Issue of the periodical within the volume

9

Country of publishing house

GB - UNITED KINGDOM

Number of pages

8

Pages from-to

2644-2651

UT code for WoS article

000818061200001

EID of the result in the Scopus database

2-s2.0-85134420398