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Intralymphatic Glut...
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Ludvigsson, JohnnyLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus
(author)
Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial
- Article/chapterEnglish2021
Publisher, publication year, extent ...
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2021-05-21
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American Diabetes Association,2021
Numbers
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LIBRIS-ID:oai:gup.ub.gu.se/307550
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https://gup.ub.gu.se/publication/307550URI
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https://doi.org/10.2337/dc21-0318DOI
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https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-108583URI
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https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-187334URI
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-178444URI
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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Funding Agency:Diamyd Medical
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Funding Agencies|Barndiabetesfonden (Swedish Child Diabetes Foundation); Diabetesfonden; Diamyd Medical
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OBJECTIVE To evaluate the efficacy of aluminum-formulated intralymphatic glutamic acid decarboxylase (GAD-alum) therapy combined with vitamin D supplementation in preserving endogenous insulin secretion in all patients with type 1 diabetes (T1D) or in a genetically prespecified subgroup. RESEARCH DESIGN AND METHODS In a multicenter, randomized, placebo-controlled, double-blind trial, 109 patients aged 12-24 years (mean +/- SD 16.4 +/- 4.1) with a diabetes duration of 7-193 days (88.8 +/- 51.4), elevated serum GAD65 autoantibodies, and a fasting serum C-peptide >0.12 nmol/L were recruited. Participants were randomized to receive either three intralymphatic injections (1 month apart) with 4 mu g GAD-alum and oral vitamin D (2,000 IE daily for 120 days) or placebo. The primary outcome was the change in stimulated serum C-peptide (mean area under the curve [AUC] after a mixed-meal tolerance test) between baseline and 15 months. RESULTS Primary end point was not met in the full analysis set (treatment effect ratio 1.091 [CI 0.845-1.408]; P = 0.5009). However, GAD-alum-treated patients carrying HLA DR3-DQ2 (n = 29; defined as DRB1*03, DQB1*02:01) showed greater preservation of C-peptide AUC (treatment effect ratio 1.557 [CI 1.126-2.153]; P = 0.0078) after 15 months compared with individuals receiving placebo with the same genotype (n = 17). Several secondary end points showed supporting trends, and a positive effect was seen in partial remission (insulin dose-adjusted HbA(1c) <= 9; P = 0.0310). Minor transient injection site reactions were reported. CONCLUSION Intralymphatic administration of GAD-alum is a simple, well-tolerated treatment that together with vitamin D supplementation seems to preserve C-peptide in patients with recent-onset T1D carrying HLA DR3-DQ2. This constitutes a disease-modifying treatment for T1D with a precision medicine approach.
Subject headings and genre
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Sumnik, Z.Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic,Charles Univ Prague, Czech Republic
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Pelikanova, T.Diabetes Centre of the Institute of Clinical and Experimental Medicine, Prague, Czech Republic,Inst Clin & Expt Med, Czech Republic
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Chavez, L. N.Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain,Hosp Univ Ramon & Cajal, Spain
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Lundberg, Elena,1961-Umeå universitet,Pediatrik,Umea Univ, Sweden(Swepub:umu)ellu0034
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Rica, I.Department of Pediatric Endocrinology, Cruces University Hospital, CIBERDEM, Bilbao, Spain,Cruces Univ Hosp, Spain
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Martinez-Brocca, M. A.Department of Endocrinology, Virgen Macarena Hospital, Sevilla, Spain,Virgen Macarena Hosp, Spain
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de Adana, M. R.Department of Adult Endocrinology and Diabetology, General University Hospital, Instituto de Biomedicina de Málaga, CIBERDEM, Malaga, Spain,Gen Univ Hosp, Spain
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Wahlberg, Jeanette,1969-Linköpings universitet,Örebro universitet,Institutionen för medicinska vetenskaper,Departments of Endocrinology Region Östergötland and Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden,Medicinska fakulteten,Avdelningen för diagnostik och specialistmedicin,Region Östergötland, Endokrinmedicinska kliniken(Swepub:liu)jeawa98
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Katsarou, A.Department of Endocrinology, Skåne University Hospital, Malmö, Sweden,Skane Univ Hosp, Sweden
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Casas, RosauraLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten(Swepub:liu)rosca56
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Hernandez, C.Department of Endocrinology and Nutrition, Vall d’Hebron Hospital, CIBERDEM, Barcelona, Spain,Vall dHebron Hosp, Spain
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Leon, M. C.Department of Endocrinology and Nutrition, Vall d’Hebron Hospital, CIBERDEM, Barcelona, Spain,Vall dHebron Hosp, Spain
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Gomez-Gila, A.Pediatric Endocrinology Service, Virgen del Rocío University Hospital, Sevilla, Spain,Virgen Roc Univ Hosp, Spain
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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; Department of Medicine, Department of Medicine, Uddevalla, Sweden,Univ Gothenburg, Sweden; Dept Med, Sweden(Swepub:gu)xostem
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Lozano, M. F.Department of Pediatric Endocrinology, Miguel Servet University Hospital, Zaragoza, Spain,Miguel Servet Univ Hosp, Spain
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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
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Samuelsson, Ulf,1951-Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus(Swepub:liu)ulfsa43
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Pruhova, S.Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic,Charles Univ Prague, Czech Republic; Motol Univ Hosp, Czech Republic
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Dietrich, FabriciaLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten(Swepub:liu)fabdi90
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Puente Marin, SaraLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten(Swepub:liu)sarpu32
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Nordlund, A.Trial Form Support, Lund, Sweden
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Hannelius, U.Diamyd Medical AB, Stockholm, Sweden,Diamyd Med AB, Sweden
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Casas, R.
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Linköpings universitetAvdelningen för barns och kvinnors hälsa
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In:Diabetes Care: American Diabetes Association44:7, s. 1604-16120149-59921935-5548
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Ludvigsson, John ...
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Sumnik, Z.
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Pelikanova, T.
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Chavez, L. N.
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Lundberg, Elena, ...
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Rica, I.
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Martinez-Brocca, ...
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de Adana, M. R.
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Wahlberg, Jeanet ...
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Katsarou, A.
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Casas, Rosaura
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Hernandez, C.
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Leon, M. C.
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Gomez-Gila, A.
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Lind, Marcus, 19 ...
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Lozano, M. F.
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Sas, T.
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Samuelsson, Ulf, ...
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Pruhova, S.
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Dietrich, Fabric ...
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Puente Marin, Sa ...
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Nordlund, A.
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Hannelius, U.
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Casas, R.
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
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Diabetes Care
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University of Gothenburg
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Örebro University
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Umeå University
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Linköping University