Intralymphatic GAD-Alum (Diamyd (R)) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2

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Intralymphatic GAD-Alum (Diamyd (R)) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2

Nowak, C. (author): Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden; Diamyd Medical AB, Stockholm, Sweden,Karolinska Inst, Sweden; Diamyd Med AB, Sweden

Lind, Marcus, 1976 (author): Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine,Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden; Sahlgrenska University Hospital, Gothenburg, Sweden; NU-Hospital Group, Uddevalla, Sweden,Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden; NU Hosp Grp, Sweden

Sumnik, Z. (author): Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic; Sahlgrenska University Hospital, Gothenburg and NU-Hospital Group, Uddevalla, Sweden,Charles Univ Prague, Czech Republic; Motol Univ Hosp, Czech Republic

Pelikanova, T. (author): Diabetes Centre of the Institute of Clinical and Experimental Medicine, Prague, Czech Republic,Inst Clin & Expt Med, Czech Republic

Chavez, L. N. (author): Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain,Hosp Univ Ramon y Cajal, Spain

Lundberg, Elena, 1961- (author): Umeå universitet,Pediatrik,Umeå Univ, Sweden

Rica, I. (author): Department of Pediatric Endocrinology, Cruces University Hospital, Bilbao, Ciberdem, Spain,Cruces Univ Hosp, Spain

Martinez-Brocca, M. A. (author): Department of Endocrinology, Virgen Macarena Hospital, Sevilla, Spain; Department of Endocrinology and Nutrition, Virgen Macarena University Hospital, Sevilla, Spain,Virgen Macarena Univ Hosp, Spain

de Adana, M. S. R. (author): Diabetes Unit. Department of Endocrinology and Nutrition. Ibima. Ciberdem. General University Hospital, Malaga, Spain,Gen Univ Hosp, Spain

Wahlberg, Jeanette, 1969- (author): Linköpings universitet,Örebro universitet,Institutionen för medicinska vetenskaper,Department of Endocrinology in Linköping, Sweden; Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden; Department of Internal Medicine, School of Health and Medical Sciences, Örebro University, Örebro, Sweden,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Endokrinmedicinska kliniken,Orebro Univ, Sweden

Casas, Rosaura, 1954- (author): Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus

Hernandez, C. (author): Department of Endocrinology and Nutrition, Vall d'Hebron Hospital, Barcelona, Ciberdem, Spain,Vall dHebron Hosp, Spain

Clemente-Leon, M. (author): Department of Endocrinology, Pediatric Service, Vall d'Hebron Hospital, Ciberer, Barcelona, Spain,Vall dHebron Hosp, Spain

Gomez-Gila, A. (author): Pediatric Endocrinology Service, Virgen del Rocío University Hospital, Sevilla, Spain,Virgen Rocio Univ Hosp, Spain

Lozano, M. F. (author): Department of Pediatric Endocrinology, Miguel Servet University Hospital, Zaragoza, Spain,Miguel Servet Univ Hosp, Spain

Sas, T. (author): Diabeter, National Treatment and Research Center for Children, Adolescents and Young Adults with type 1 diabetes, and Department of Pediatric Endocrinology, Erasmus University Medical Center, Rotterdam, The Netherlands

Pruhova, S. (author): Department of Pediatrics, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic; Motol University Hospital, Prague, Czech Republic,Charles Univ Prague, Czech Republic; Motol Univ Hosp, Czech Republic

Dietrich, Fabricia (author): Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten

Puente Marin, Sara (author): Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten

Hannelius, U. (author): Diamyd Medical AB, Stockholm, Sweden,Diamyd Med AB, Sweden

Casas, R. (author)

Ludvigsson, Johnny, 1943- (author): Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus

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2022-06-06
2022
English.
In: Journal of Clinical Endocrinology & Metabolism. - : The Endocrine Society. - 0021-972X .- 1945-7197. ; 107:9, s. 2644-2651

Related links:: https://doi.org/10.1...; show more...; https://umu.diva-por... (primary) (Raw object); https://gup.ub.gu.se...; https://doi.org/10.1...; https://urn.kb.se/re...; https://urn.kb.se/re...; https://urn.kb.se/re...; http://kipublication...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

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 > 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 > 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

Keyword

type 1 diabetes
GAD-alum
GAD65
Diamyd
HLA DR3-DQ2
continuous
glucose monitoring
C-peptide
HbA1c
antigen-specific immune therapy
complications
hypoglycemia
retinopathy
impact
Endocrinology & Metabolism
C-peptide

Publication and Content Type

ref (subject category)
art (subject category)

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Endocrinology an ...

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