Clinical Trials

Date: 2017-09-21

Type of information: Clinical trial authorisation

phase: 2

Announcement: clinical trial authorisation

Company: Diamyd Medical (Sweden)

Product: Diamyd®

Action mechanism:

• protein. Diamyd® is an antigen-based diabetes therapy under development to prevent, delay, or stop the autoimmune attack on beta cells in type 1 diabetes and other forms of autoimmune diabetes, thereby preserving the body's capacity to regulate blood sugar. The active substance in the Diamyd® diabetes vaccine is glutamic acid decarboxylase isoform 65kDa (GAD). GAD is one of the most important targets when the immune system attacks the beta cells in autoimmune diabetes. Accordingly, GAD is an autoantigen. Treatment using Diamyd® is intended to stop the autoimmune attack against the beta cells by inducing tolerance to GAD.

Disease: type 1 diabetes

Therapeutic area: Autoimmune diseases - Metabolic diseases

Country: Czech Republic, Spain, Sweden

Trial details:

• DIAGNODE-2 is a clinical trial in children and young adults recently diagnosed with type 1 diabetes. This placebo-controlled Phase II trial is a pivotal follow-up trial where the diabetes vaccine Diamyd® is administered directly into the lymph node. DIAGNODE-2 will be conducted at a number of selected clinics in some countries in Europe including Sweden. The trial includes approximately 80 patients aged 12-24 years, recently diagnosed with type 1 diabetes, and the patients will be followed for 15 months. The aim of the trial is to evaluate the effect of the treatment in preserving the patients' insulin producing capacity. The Coordinating Investigator for the trial is Professor Johnny Ludvigsson at Linköping University.
• The decision to conduct the trial is based on highly promising preliminary clinical results from the ongoing open-label DIAGNODE-1 trial in which children and adolescents recently diagnosed with type 1 diabetes are given Diamyd® directly into the lymph node. The clinical effect of preserving the patient’s own insulin production is estimated to be significantly improved when the diabetes vaccine Diamyd® is administered directly into the lymph node, as compared to injecting it under the skin as in previous Phase III trials. The Diamyd Medical patent pending concept can be compared to the development of allergy treatment where it has been found that the administration of allergen into the lymph node significantly improves the treatment effect.

Latest news:

•  • On September 21, 2017, Diamyd Medical announced that Phase II trial DIAGNODE-2 with the diabetes vaccine Diamyd® approved to start in all participating countries. Spanish and Czech Competent Authorities and the relevant Ethics Committees have approved the application to conduct DIAGNODE-2. Previously, the trial has been approved by the Swedish Medical Products Agency and the Ethics Committee. Contract writing with all participating clinics, packing and blinding of study drugs and validation of systems and processes to be used in the trial scheduled for the autumn, is ongoing. Trial details and processes will be presented to investigators and nurses from participating clinics at the Investigators meeting, which will be held by Diamyd Medical in Barcelona, Spain, on 5-6 October.
• • On June 27, 2017, Diamyd Medical announced that the company has received approval from the Swedish Medical Products Agency for the Phase II trial DIAGNODE-2. The clinical trial is expected to commence patient recruitment by the autumn of 2017.
• • On May 22, 2017, Diamyd Medical announced that the Company has submitted an application to the Swedish Medical Products Agency to conduct DIAGNODE-2, a pivotal follow-up clinical trial in children and adolescents recently diagnosed with type 1 diabetes. The placebo-controlled Phase II trial will investigate an innovative and patent-pending concept, where the diabetes vaccine Diamyd® is administered directly into the lymph nodes. The trial is financed by Diamyd Medical, sponsor of the trial, through funds from the ongoing rights issue with the subscription period 10 - 24 May 2017.
• • On April 21, 2017, Diamyd Medical announced that the company  has contracted the global CRO TFS Trial Form Support International for the conduction of DIAGNODE-2, a clinical trial in children and young adults recently diagnosed with type 1 diabetes. The placebo-controlled Phase II trial is a pivotal follow-up trial with an innovative and patent-pending concept where the diabetes vaccine Diamyd® is administered directly into the lymph node. The trial is expected to start recruiting patients in the fall of 2017.
• The decision to conduct the trial is based on preliminary clinical results from the ongoing open-label DIAGNODE-1 trial in which children and adolescents recently diagnosed with type 1 diabetes are given Diamyd® directly into the lymph node. The clinical effect of preserving the patient’s own insulin production is estimated to be significantly improved when the diabetes vaccine Diamyd® is administered directly into the lymph node, as compared to injecting it under the skin as in previous Phase III trials. The Diamyd Medical patent pending concept can be compared to the development of allergy treatment where it has been found that the administration of allergen into the lymph node significantly improves the treatment effect.

Is general: Yes