A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetes
Phase of Trial: Phase II
Latest Information Update: 30 Jul 2018
At a glance
- Drugs GAD65 vaccine (Diamyd) (Primary)
- Indications Type 1 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms DIAGNODE-2
- Sponsors Diamyd Medical AB
- 25 Jul 2018 Planned number of patients changed from 80 to 106.
- 23 Apr 2018 According to a Diamyd Medical AB media release ,as of April 23, 54 patients have been screened, of these, 40 have already been included in the trial.
- 02 Mar 2018 According to a Diamyd Medical AB media release, to date, 9 patients have been included in the trial and approximately 100 patients are planned to be screened in order for 80 patients to be included. The Company estimates that the rate of recruitment is in line with the target; fully recruited trial in November 2018.