GLUTAMATE DECARBOXYLASE 2

also known as rhGAD65 · Diamyd · GAD-alum · Diamyd antigen gad-65 · GAD65 · recombinant human glutamic acid dehydrogenase · Rhugad65

Vaccine

Developed for: type 1 diabetes mellitus · latent autoimmune diabetes in adults
Investigated by: Diamyd Medical AB · Diamyd Therapeutics AB · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · American Diabetes Association · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Johnny Ludvigsson
+9 more
· Juvenile Diabetes Research Foundation · Karolinska Institutet · Linkoeping University · National Center for Research Resources (NCRR) · National Institute of Allergy and Infectious Diseases (NIAID) · Norwegian University of Science and Technology · Ostergotland County Council, Sweden · St. Olavs Hospital · Swedish Child Diabetes Foundation

Trials 7 · a red edge is where a trial was stopped

today NCT05018585 · Ph 3 NCT04262479 · Ph 2 NCT02464033 · Ph 2 NCT00837759 · Ph 2 NCT00529399 · Ph 2 NCT00435981 · Ph 2 NCT00456027 · Ph 2

200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 26 trials
Phase 2	NCT04262479	Mar 2020 → May 2022	latent autoimmune diabetes in adults	Norwegian University of Science and Technology	Completed	No outcome recorded
Phase 2	NCT02464033	May 2015 → Feb 2019	type 1 diabetes mellitus	Johnny Ludvigsson	Completed	No outcome recorded
Phase 2	NCT00837759	Feb 2009 → Mar 2011	type 1 diabetes mellitus	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Terminated	No outcome recorded
Phase 2	NCT00529399	Feb 2009 → May 2012	type 1 diabetes mellitus	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	No outcome recorded
Phase 2	NCT00435981	Jan 2005 → Oct 2007	type 1 diabetes mellitus	Diamyd Therapeutics AB	Completed	No outcome recorded
Phase 2	NCT00456027	Dec 2004 → Mar 2008	latent autoimmune diabetes in adults	Diamyd Therapeutics AB	Completed	No outcome recorded
Phase 31 trial
Phase 3	NCT05018585	May 2022 → Dec 2027 expected	type 1 diabetes mellitus	Diamyd Medical AB	Active not recruiting	No outcome recorded

Also used as a comparator or background therapy in 3 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 21 trial
Phase 2	NCT03345004 Comparator	Dec 2017 → Jul 2020	type 1 diabetes mellitus	Diamyd Medical AB	Completed	No outcome recorded
Phase 32 trials
Phase 3	NCT00751842 Comparator	Sep 2008 → Mar 2012	type 1 diabetes mellitus	Diamyd Therapeutics AB	Terminated	No outcome recorded
Phase 3	NCT00723411 Comparator	Jul 2008 → May 2011	type 1 diabetes mellitus	Diamyd Therapeutics AB	Terminated	No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

Field	Value	Cited text
Known as	GLUTAMATE DECARBOXYLASE 2	ChEMBL registry synonym — accepted as the source's own label CHEMBL4594599 ↗
Known as	Diamyd	“This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously...” NCT00435981 ↗ 2 “The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients...” NCT00751842 ↗ “GAD65 (Diamyd)” NCT00837759 ↗
Known as	Diamyd antigen gad-65	ChEMBL registry synonym — accepted as the source's own label CHEMBL4594599 ↗
Known as	GAD-alum	“BACKGROUND: This study aimed to analyse data from two different studies (phase II and phase III) regarding the safety and efficacy of treatment with alum formulated glutamic...” PMID 24302596 ↗ Jul 2014 1 “GAD-Alum is Recombinant human (rhGAD65) and is used as an antigen-specific immune modulator.” NCT00529399 ↗
Known as	GAD65	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00837759 ↗
Known as	recombinant human glutamic acid dehydrogenase	“recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel” NCT04262479 ↗
Known as	rhGAD65	“GAD-Alum is Recombinant human (rhGAD65) and is used as an antigen-specific immune modulator.” NCT00529399 ↗ 8 “Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65)” NCT03345004 ↗ “Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)” NCT02464033 ↗ NCT00435981 ↗ NCT04262479 ↗ NCT05018585 ↗ NCT00751842 ↗ NCT00456027 ↗ NCT00723411 ↗
Known as	Rhugad65	ChEMBL registry synonym — accepted as the source's own label CHEMBL4594599 ↗
Modality	Vaccine	“who received subcutaneous GAD-alum vaccination” PMID 28357504 ↗ Mar 2017
Route	Subcutaneous	“20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart” NCT00435981 ↗