Intralymphatic GAD-alum (Diamyd(R)) improves glycaemic control in Type 1 diabetes with HLA DR3-DQ2
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F22%3A10444306" target="_blank" >RIV/00064203:_____/22:10444306 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11130/22:10444306
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=eu~QKAuJEK" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=eu~QKAuJEK</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1210/clinem/dgac343" target="_blank" >10.1210/clinem/dgac343</a>
Alternative languages
Result language
angličtina
Original language name
Intralymphatic GAD-alum (Diamyd(R)) improves glycaemic 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(R)) given in three intralymphatic injections with oral Vitamin D has shown promising results in persons with T1D carrying the HLA DR3-DQ2 haplotype in the phase IIb 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 12-24 years with GAD65 antibodies and fasting C-peptide >0.12 nmol/L, which randomized patients to three intralymphatic injections of 4 μg 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, % time in range (TIR, 3.9-10 mmol/L) declined less between baseline and Month 15 in GAD-alum-treated compared to placebo-treated patients (-5.1% and -16.7%, respectively, p=0.0075), with reduced time >13.9 mmol/L (p=0.0036), and significant benefits on the glucose management indicator (p=0.0025). No differences were detected for hypoglycaemia. GAD-alum compared to placebo lowered the increase in glycaemic 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 glycaemic control in recently diagnosed T1D patients carrying HLA DR3-DQ2.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - 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)
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2022
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
The Journal of Clinical Endocrinology & 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
US - UNITED STATES
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