A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes

Summary

The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype.

Timeline

Start

2022-05-19

Primary completion

2027-12

Completion

2027-12

Outcome

Missed primary endpoint

release “Diamyd Medical discontinued DIAGNODE-3 following evaluation confirming futility and initiated strategic review” diamyd.com ↗

Publications

• Ludvigsson J, Eriksson L, Nowak C, Teixeira PF, Widman M, Lindqvist A, Casas R, Lind M, Hannelius U. 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. BMJ Open. 2022 Oct 31;12(10):e061776. doi: 10.1136/bmjopen-2022-061776.

Drugs

Indications