Phase III, randomised, double-blind, placebo-controlled, multicentre trial to evaluate the efficacy and safety of rhGAD65 to preserve endogenous beta cell function in adolescents and adults with recently diagnosed type 1 diabetes, carrying the genetic HLA DR3-DQ2 haplotype: the DIAGNODE-3 study protocol.
Johnny LudvigssonLinnea ErikssonChristoph NowakPedro F TeixeiraMartina WidmanAnton LindqvistRosaura CasasMarcus LindUlf HanneliusPublished in: BMJ open (2022)
EudraCT identifier: 2021-002731-32, NCT identifier: NCT05018585.
Keyphrases
- phase iii
- placebo controlled
- double blind
- study protocol
- type diabetes
- clinical trial
- phase ii
- young adults
- open label
- randomized controlled trial
- physical activity
- genome wide
- phase ii study
- glycemic control
- editorial comment
- cardiovascular disease
- insulin resistance
- celiac disease
- copy number
- metabolic syndrome
- squamous cell carcinoma
- dna methylation
- gene expression
- weight loss
- adipose tissue