Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

December 20, 2017

Primary Completion Date

July 13, 2020

Study Completion Date

April 27, 2021

Conditions
Diabetes Mellitus, Type 1Diabetes MellitusAutoimmune DiseasesMetabolic DiseaseGlucose Metabolism DisordersImmune System DiseasesEndocrine System DiseasesJuvenile DiabetesInsulin Dependent DiabetesAutoimmune DiabetesVitamin DPhysiological Effects of Drugs
Interventions
BIOLOGICAL

Diamyd

Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65)

DIETARY_SUPPLEMENT

Vitamin D

Oil suspension of Vitamin D

BIOLOGICAL

Placebo for Diamyd

Alhydrogel® only

DIETARY_SUPPLEMENT

Placebo for Vitamin D

Placebo oil suspension for Vitamin D

Trial Locations (18)

14021

Diabetes Centre, Institute of Clinical and Experimental Medicine, Prague

15006

Department of Paediatrics, University Hospital Motol, Prague

20502

Barn-och Ungdomsmedicinmottagningen and Endokrinmottagningen, Skånes Universitetssjukhus, Malmo

28033

Adult Endocrinology and Diabetology, Hospital Ramón y Cajal, Madrid

29009

Adult Endocrinology and Diabetology, Hospital Carlos Haya, Málaga

29011

Pediatrics Endocrinology and Diabetology, Hospital Materno-Ifantil, Málaga

41009

Adult Endocrinology and Diabetology, Hospital Macarena, Seville

41013

Pediatrics Endocrinology and Diabetology, Hospital Virgen del Rocío, Seville

45180

Barn- och ungdomskliniken, Uddevalla Sjukhus, Uddevalla

Diabetesmottagningen, Uddevalla Sjukhus, Uddevalla

48903

Adult and Pediatrics Endocrinology and Diabetology, Hospital Universitario Cruces, Barakaldo

50009

Adult and Pediatrics Endocrinology and Diabetology, Hospital Miguel Servet, Zaragoza

58185

Barn- och Ungdomskliniken, Universitetssjukhuset, Linköping

Endokrinmedicinska kliniken. Universitetssjukhuset, Linköping

3011 TA

Diabeter Rotterdam, Rotterdam

08035

Adult Endocrinology and Diabetology, Hospital vall D' Hebrón, Barcelona

Pediatrics Endocrinology and Diabetology, Hospital Vall D'Hebrón, Barcelona

901 85

Barnmottagningen, Norrlands Universitetssjukhus, Umeå

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Diamyd Medical AB

INDUSTRY

NCT03345004 - Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes | Biotech Hunter | Biotech Hunter