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Intralymphatic GAD-...
Intralymphatic GAD-Alum (Diamyd (R)) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2
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- Nowak, C. (författare)
- Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden; Diamyd Medical AB, Stockholm, Sweden,Karolinska Inst, Sweden; Diamyd Med AB, Sweden
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- Lind, Marcus, 1976 (författare)
- 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
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- Sumnik, Z. (författare)
- 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
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- Pelikanova, T. (författare)
- 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. (författare)
- Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain,Hosp Univ Ramon y Cajal, Spain
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- Lundberg, Elena, 1961- (författare)
- Umeå universitet,Pediatrik,Umeå Univ, Sweden
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- Rica, I. (författare)
- Department of Pediatric Endocrinology, Cruces University Hospital, Bilbao, Ciberdem, Spain,Cruces Univ Hosp, Spain
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- Martinez-Brocca, M. A. (författare)
- Department of Endocrinology, Virgen Macarena Hospital, Sevilla, Spain; Department of Endocrinology and Nutrition, Virgen Macarena University Hospital, Sevilla, Spain,Virgen Macarena Univ Hosp, Spain
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- de Adana, M. S. R. (författare)
- Diabetes Unit. Department of Endocrinology and Nutrition. Ibima. Ciberdem. General University Hospital, Malaga, Spain,Gen Univ Hosp, Spain
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- Wahlberg, Jeanette, 1969- (författare)
- 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
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- Casas, Rosaura, 1954- (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus
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- Hernandez, C. (författare)
- Department of Endocrinology and Nutrition, Vall d'Hebron Hospital, Barcelona, Ciberdem, Spain,Vall dHebron Hosp, Spain
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- Clemente-Leon, M. (författare)
- Department of Endocrinology, Pediatric Service, Vall d'Hebron Hospital, Ciberer, Barcelona, Spain,Vall dHebron Hosp, Spain
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- Gomez-Gila, A. (författare)
- Pediatric Endocrinology Service, Virgen del Rocío University Hospital, Sevilla, Spain,Virgen Rocio Univ Hosp, Spain
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- Lozano, M. F. (författare)
- Department of Pediatric Endocrinology, Miguel Servet University Hospital, Zaragoza, Spain,Miguel Servet Univ Hosp, Spain
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- Sas, T. (författare)
- 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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- Pruhova, S. (författare)
- 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
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- Dietrich, Fabricia (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten
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- Puente Marin, Sara (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten
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- Hannelius, U. (författare)
- Diamyd Medical AB, Stockholm, Sweden,Diamyd Med AB, Sweden
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Casas, R. (författare)
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- Ludvigsson, Johnny, 1943- (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus
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(creator_code:org_t)
- 2022-06-06
- 2022
- Engelska.
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Ingår i: Journal of Clinical Endocrinology & Metabolism. - : The Endocrine Society. - 0021-972X .- 1945-7197. ; 107:9, s. 2644-2651
- Relaterad länk:
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https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://urn.kb.se/re...
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https://urn.kb.se/re...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- 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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- 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
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
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Nowak, C.
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Lind, Marcus, 19 ...
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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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visa fler...
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Rica, I.
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Martinez-Brocca, ...
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de Adana, M. S. ...
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Wahlberg, Jeanet ...
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Casas, Rosaura, ...
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Hernandez, C.
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Clemente-Leon, M ...
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Gomez-Gila, A.
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Lozano, M. F.
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Sas, T.
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Pruhova, S.
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Dietrich, Fabric ...
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Puente Marin, Sa ...
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Hannelius, U.
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Casas, R.
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Ludvigsson, John ...
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Endokrinologi oc ...
- Artiklar i publikationen
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Journal of Clini ...
- Av lärosätet
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Göteborgs universitet
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Örebro universitet
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Umeå universitet
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Linköpings universitet
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Karolinska Institutet