Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial

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Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial

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

Sumnik, Z. (author): Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic,Charles Univ Prague, 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 & Cajal, Spain

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

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

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

de Adana, M. R. (author): Department of Adult Endocrinology and Diabetology, General University Hospital, Instituto de Biomedicina de Málaga, CIBERDEM, Malaga, Spain,Gen Univ Hosp, Spain

Wahlberg, Jeanette, 1969- (author): 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

Katsarou, A. (author): Department of Endocrinology, Skåne University Hospital, Malmö, Sweden,Skane Univ Hosp, Sweden

Casas, Rosaura (author): Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten

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

Leon, M. C. (author): Department of Endocrinology and Nutrition, Vall d’Hebron Hospital, CIBERDEM, Barcelona, Spain,Vall dHebron Hosp, Spain

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

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; Department of Medicine, Department of Medicine, Uddevalla, Sweden,Univ Gothenburg, Sweden; Dept Med, Sweden

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

Samuelsson, Ulf, 1951- (author): Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus

Pruhova, S. (author): 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

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

Nordlund, A. (author): Trial Form Support, Lund, Sweden

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

Casas, R. (author)

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2021-05-21
2021
English.
In: Diabetes Care. - : American Diabetes Association. - 0149-5992 .- 1935-5548. ; 44:7, s. 1604-1612

Related links:: https://care.diabete...; show more...; https://doi.org/10.2...; https://gup.ub.gu.se...; https://doi.org/10.2...; https://urn.kb.se/re...; https://urn.kb.se/re...; https://urn.kb.se/re...; show less...

Journal article (peer-reviewed)

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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.

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

Articles in the publication: Diabetes Care

By the university: University of Gothenburg; Örebro University; Umeå University; Linköping University

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Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial

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