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

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

  • Artikel/kapitelEngelska2022

Förlag, utgivningsår, omfång ...

  • 2022-06-06
  • The Endocrine Society,2022

Nummerbeteckningar

  • LIBRIS-ID:oai:gup.ub.gu.se/320312
  • https://gup.ub.gu.se/publication/320312URI
  • https://doi.org/10.1210/clinem/dgac343DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-99531URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-203239URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-187540URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:150045179URI

Kompletterande språkuppgifter

  • Språk:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding agency:Diamyd Medical AB
  • Funding Agencies|Diamyd Medical AB; Barndiabetesfonden (Swedish Child Diabetes Foundation); Diabetesfonden (Swedish Diabetes Association)
  • 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.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Lind, Marcus,1976Gothenburg 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(Swepub:gu)xostem (författare)
  • Sumnik, Z.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 (författare)
  • Pelikanova, T.Diabetes Centre of the Institute of Clinical and Experimental Medicine, Prague, Czech Republic,Inst Clin & Expt Med, Czech Republic (författare)
  • Chavez, L. N.Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain,Hosp Univ Ramon y Cajal, Spain (författare)
  • Lundberg, Elena,1961-Umeå universitet,Pediatrik,Umeå Univ, Sweden(Swepub:umu)ellu0034 (författare)
  • Rica, I.Department of Pediatric Endocrinology, Cruces University Hospital, Bilbao, Ciberdem, Spain,Cruces Univ Hosp, Spain (författare)
  • Martinez-Brocca, M. A.Department of Endocrinology, Virgen Macarena Hospital, Sevilla, Spain; Department of Endocrinology and Nutrition, Virgen Macarena University Hospital, Sevilla, Spain,Virgen Macarena Univ Hosp, Spain (författare)
  • de Adana, M. S. R.Diabetes Unit. Department of Endocrinology and Nutrition. Ibima. Ciberdem. General University Hospital, Malaga, Spain,Gen Univ Hosp, Spain (författare)
  • Wahlberg, Jeanette,1969-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(Swepub:liu)jeawa98 (författare)
  • Casas, Rosaura,1954-Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus(Swepub:liu)rosca56 (författare)
  • Hernandez, C.Department of Endocrinology and Nutrition, Vall d'Hebron Hospital, Barcelona, Ciberdem, Spain,Vall dHebron Hosp, Spain (författare)
  • Clemente-Leon, M.Department of Endocrinology, Pediatric Service, Vall d'Hebron Hospital, Ciberer, Barcelona, Spain,Vall dHebron Hosp, Spain (författare)
  • Gomez-Gila, A.Pediatric Endocrinology Service, Virgen del Rocío University Hospital, Sevilla, Spain,Virgen Rocio Univ Hosp, Spain (författare)
  • Lozano, M. F.Department of Pediatric Endocrinology, Miguel Servet University Hospital, Zaragoza, Spain,Miguel Servet Univ Hosp, Spain (författare)
  • Sas, T.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 (författare)
  • Pruhova, S.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 (författare)
  • Dietrich, FabriciaLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten(Swepub:liu)fabdi90 (författare)
  • Puente Marin, SaraLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten(Swepub:liu)sarpu32 (författare)
  • Hannelius, U.Diamyd Medical AB, Stockholm, Sweden,Diamyd Med AB, Sweden (författare)
  • Casas, R. (författare)
  • Ludvigsson, Johnny,1943-Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus(Swepub:liu)johlu29 (författare)
  • Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden; Diamyd Medical AB, Stockholm, SwedenKarolinska Inst, Sweden; Diamyd Med AB, Sweden (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Journal of Clinical Endocrinology & Metabolism: The Endocrine Society107:9, s. 2644-26510021-972X1945-7197

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