GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus

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Fältnamn	Indikatorer	Metadata
000		08705naa a2201225 4500
001		oai:DiVA.org:liu-89965
003		SwePub
008		130312s2012 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
009		oai:lup.lub.lu.se:de435ab5-1cd0-439f-a07b-2e8f2a47b88f
024	7	a https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-899652 URI
024	7	a https://doi.org/10.1056/NEJMoa11070962 DOI
024	7	a https://lup.lub.lu.se/record/de435ab5-1cd0-439f-a07b-2e8f2a47b88f2 URI
040		a (SwePub)liud (SwePub)lu
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Ludvigsson, Johnnyu Linköping University,Östergötlands Läns Landsting,Linköpings universitet,Pediatrik,Hälsouniversitetet,Barn- och ungdomskliniken i Linköping4 aut0 (Swepub:liu)johlu29
245	1 0	a GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus
264	1	b Massachusetts Medical Society,c 2012
338		a print2 rdacarrier
500		a Funding Agencies\|Diamyd Medical\|\|Swedish Child Diabetes Foundation (Barndiabetesfonden)
520		a BACKGROUND: The 65-kD isoform of glutamic acid decarboxylase (GAD65) is a major autoantigen in type 1 diabetes. We hypothesized that alum-formulated GAD65 (GAD-alum) can preserve beta-cell function in patients with recent-onset type 1 diabetes.METHODS: We studied 334 patients, 10 to 20 years of age, with type 1 diabetes, fasting C-peptide levels of more than 0.3 ng per milliliter (0.1 nmol per liter), and detectable serum GAD65 autoantibodies. Within 3 months after diagnosis, patients were randomly assigned to receive one of three study treatments: four doses of GAD-alum, two doses of GAD-alum followed by two doses of placebo, or four doses of placebo. The primary outcome was the change in the stimulated serum C-peptide level (after a mixed-meal tolerance test) between the baseline visit and the 15-month visit. Secondary outcomes included the glycated hemoglobin level, mean daily insulin dose, rate of hypoglycemia, and fasting and maximum stimulated C-peptide levels.RESULTS: The stimulated C-peptide level declined to a similar degree in all study groups, and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group (P=0.10). The use of GAD-alum as compared with placebo did not affect the insulin dose, glycated hemoglobin level, or hypoglycemia rate. Adverse events were infrequent and mild in the three groups, with no significant differences.CONCLUSIONS: Treatment with GAD-alum did not significantly reduce the loss of stimulated C peptide or improve clinical outcomes over a 15-month period.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Endokrinologi och diabetes0 (SwePub)302052 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Endocrinology and Diabetes0 (SwePub)302052 hsv//eng
653		a MEDICINE
653		a MEDICIN
700	1	a Krisky, Davidu Diamyd Medical, Pittsburgh,Diamyd Medical, US4 aut
700	1	a Casas, Rosaurau Linköping University,Linköpings universitet,Pediatrik,Hälsouniversitetet4 aut0 (Swepub:liu)rosca56
700	1	a Battelino, Tadeju University Medical Center–University Children's Hospital, Faculty of Medicine, Ljubljana, Slovenia4 aut
700	1	a Castaño, Luisu Hospital de Cruces–University of Basque Country, Barakaldo, Bizkaia, Spain4 aut
700	1	a Greening, Jamesu Department of Paediatrics, Leicester Royal Infirmary, Leicester, UK4 aut
700	1	a Kordonouri, Olgau Diabetes Center for Children and Adolescents, Kinderkrankenhaus auf der Bult, Hannover, Germany,Children's Hospital Auf der Bult4 aut
700	1	a Otonkoski, Timou Children's Hospital, University of Helsinki, and Helsinki University Central Hospital, Helsinki, Finland4 aut
700	1	a Pozzilli, Paolou University Campus Bio-Medico, Rome, Italy4 aut
700	1	a Robert, Jean-Jacquesu Hôpital Necker–Enfants Malades, Université René Descartes Paris 5, Paris, France4 aut
700	1	a Veeze, Henk J.u Stichting Diabeter, Rotterdam, the Netherlands4 aut
700	1	a Palmer, Jerryu Department of Medicine, Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, USA4 aut
700	1	a Samuelsson, Ulfu Östergötlands Läns Landsting,Linköpings universitet,Pediatrik,Hälsouniversitetet,Barn- och ungdomskliniken i Linköping4 aut0 (Swepub:liu)ulfsa43
700	1	a Elding Larsson, Helenau Lund University,Lunds universitet,Pediatrisk endokrinologi,Forskargrupper vid Lunds universitet,Paediatric Endocrinology,Lund University Research Groups4 aut0 (Swepub:lu)pedi-hla
700	1	a Åman, Janu Örebro universitet, Sweden4 aut
700	1	a Kärdell, Gunilla4 aut
700	1	a Neiderud, Janu Helsingborgs lasarett, Sweden4 aut
700	1	a Lundström, Göranu Länssjukhuset Kalmar, Sweden4 aut
700	1	a Albinsson, Evau Linköpings universitet,Institutionen för klinisk och experimentell medicin,Hälsouniversitetet4 aut0 (Swepub:liu)evaal82
700	1	a Carlsson, Annelieu Lund University,Lunds universitet,Pediatrisk autoimmunitet,Forskargrupper vid Lunds universitet,Pediatric Autoimmunity,Lund University Research Groups4 aut0 (Swepub:lu)med-acs
700	1	a Nordvall, Mariau Östergötlands Läns Landsting,Linköpings universitet,Pediatrik,Hälsouniversitetet,Barn- och ungdomskliniken i Norrköping4 aut
700	1	a Fors, Hansu Sahlgrenska akademin vid Göteborgs universitet, Sweden4 aut
700	1	a Arvidsson, Carl-Göranu Centrallasarettet, Västerås, Sweden4 aut
700	1	a Edvardson, Stigu Centrallasarettet, Växjö, Sweden4 aut
700	1	a Hanås, Ragnaru Linköpings universitet,Pediatrik,Hälsouniversitetet4 aut0 (Swepub:liu)ragha78
700	1	a Larsson, Karin4 aut
700	1	a Rathsman, Björnu Sachsska Barnsjukhuset, Stockholm, Sweden4 aut
700	1	a Forsgren, Henrik4 aut
700	1	a Desaix, Helena4 aut
700	1	a Forsander, Gunu Göteborg University, Sweden4 aut
700	1	a Nilsson, Nils-Östenu Lasarettet i Halmstad, Sweden4 aut
700	1	a Åkesson, Carl-Göran4 aut
700	1	a Keskinen, Päiviu University of Tampere, Finland4 aut
700	1	a Veijola, Riittau Uleåborgs universitetssjukhus, Finland4 aut
700	1	a Talvitie, Timo4 aut
700	1	a Raile, Klemensu Charite, Berlin, Germany4 aut
700	1	a Kapellen, Thomasu University of Leipzig, Germany4 aut
700	1	a Burger, Walter4 aut
700	1	a Neu, Andreasu University Children's Hospital, Tuebingen, Germany4 aut
700	1	a Engelsberger, Ilse4 aut
700	1	a Heidtmann, Bettinau Catholic Children’s Hospital Wilhelmstift, Hamburg, Germany4 aut
700	1	a Bechtold, Suzanne4 aut
700	1	a Leslie, Davidu Blizard Institute, Queen Mary University of London, UK4 aut
700	1	a Chiarelli, Francescou University of Chieti, Italy4 aut
700	1	a Cicognani, Alesandrou University of Bologna, Italy4 aut
700	1	a Chiumello, Giuseppeu Vita-Salute University, Milan, Italy4 aut
700	1	a Cerutti, Francou University of Turin, Italy4 aut
700	1	a Zuccotti, Gian Vincenzou University of Milan, Italy4 aut
700	1	a Gomez Gila, Ana4 aut
700	1	a Rica, Itxaso4 aut
700	1	a Barrio, Raquel4 aut
700	1	a Clemente, Maria4 aut
700	1	a López Garcia, Maria José4 aut
700	1	a Rodriguez, Mercedes4 aut
700	1	a Gonzalez, Isabel4 aut
700	1	a Lopez, Juan Pedro4 aut
700	1	a Oyarzabal, Mirentxu4 aut
700	1	a Reeser, H M4 aut
700	1	a Nuboer, Roos4 aut
700	1	a Stouthart, Pauline4 aut
700	1	a Bratina, Natasa4 aut
700	1	a Bratanic, Nina4 aut
700	1	a de Kerdanet, Marc4 aut
700	1	a Weill, Jacques4 aut
700	1	a Ser, Nicole4 aut
700	1	a Barat, Pascal4 aut
700	1	a Bertrand, Anne Marie4 aut
700	1	a Carel, Jean-Claude4 aut
700	1	a Reynaud, Rachel4 aut
700	1	a Coutant, Regis4 aut
700	1	a Baron, Sabine4 aut
710	2	a Linköpings universitetb Pediatrik4 org
710	2	a Co-authors
773	0	t New England Journal of Medicined : Massachusetts Medical Societyg 366:5, s. 433-442q 366:5<433-442x 0028-4793x 1533-4406
856	4	u http://www.ncbi.nlm.nih.gov/pubmed/22296077y Länk till posten i PubMed
856	4	u http://dx.doi.org/10.1056/NEJMoa1107096y FULLTEXT
856	4 8	u https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-89965
856	4 8	u https://doi.org/10.1056/NEJMoa1107096
856	4 8	u https://lup.lub.lu.se/record/de435ab5-1cd0-439f-a07b-2e8f2a47b88f

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Av författaren/redakt...: Ludvigsson, John ...; Krisky, David; Casas, Rosaura; Battelino, Tadej; Castaño, Luis; Greening, James; visa fler...; Kordonouri, Olga; Otonkoski, Timo; Pozzilli, Paolo; Robert, Jean-Jac ...; Veeze, Henk J.; Palmer, Jerry; Samuelsson, Ulf; Elding Larsson, ...; Åman, Jan; Kärdell, Gunilla; Neiderud, Jan; Lundström, Göran; Albinsson, Eva; Carlsson, Anneli ...; Nordvall, Maria; Fors, Hans; Arvidsson, Carl- ...; Edvardson, Stig; Hanås, Ragnar; Larsson, Karin; Rathsman, Björn; Forsgren, Henrik; Desaix, Helena; Forsander, Gun; Nilsson, Nils-Ös ...; Åkesson, Carl-Gö ...; Keskinen, Päivi; Veijola, Riitta; Talvitie, Timo; Raile, Klemens; Kapellen, Thomas; Burger, Walter; Neu, Andreas; Engelsberger, Il ...; Heidtmann, Betti ...; Bechtold, Suzann ...; Leslie, David; Chiarelli, Franc ...; Cicognani, Alesa ...; Chiumello, Giuse ...; Cerutti, Franco; Zuccotti, Gian V ...; Gomez Gila, Ana; Rica, Itxaso; Barrio, Raquel; Clemente, Maria; López Garcia, Ma ...; Rodriguez, Merce ...; Gonzalez, Isabel; Lopez, Juan Pedr ...; Oyarzabal, Miren ...; Reeser, H M; Nuboer, Roos; Stouthart, Pauli ...; Bratina, Natasa; Bratanic, Nina; de Kerdanet, Mar ...; Weill, Jacques; Ser, Nicole; Barat, Pascal; Bertrand, Anne M ...; Carel, Jean-Clau ...; Reynaud, Rachel; Coutant, Regis; Baron, Sabine; visa färre...

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