Date: 2014-11-11
Type of
information: Clinical trial authorization
phase: 1
Announcement: clinical trial authorisation
Company: Diamyd Medical (Sweden) University of Alabama at Birmingham (USA - AL)
Product: Diamyd® (glutamic acid decarboxylase - GAD) and Gamma-Amino Butyric Acid (GABA)
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: USA
Trial
details:
- The clinical study is a three-arm, double-blind, placebo-controlled trial and will enroll a total of 75 newly diagnosed type 1 diabetes children and adolescents between 4 and 18 years of age. Patients will be assigned to one of three treatment groups to receive either: a) two injections of Diamyd® plus GABA for 12 months; b) GABA only; or c) placebo. Patients will be followed for a total of 12 months, after which the effect on preserving endogenous insulin production will be analyzed. (NCT02002130)
Latest
news:
- • On November 11, 2014, Diamyd Medical announced that an investigator initiated study combining the diabetes vaccine Diamyd® and GABA in children with new onset type 1 diabetes has been approved by the FDA. Diamyd Medical and University of Alabama at Birmingham have entered a Clinical Trial Agreement regarding the study, which will be conducted at Children's of Alabama in Birmingham, USA. The combination has shown promising results in preclinical studies. Principal Investigator for the new GABA and Diamyd® combination study is Kenneth McCormick, MD, Professor of Pediatrics at University of Alabama at Birmingham.
Diamyd Medical has in-licensed exclusive rights for therapeutic use of GABA (gamma-aminobutyric acid) for the treatment of diabetes and other inflammation-related conditions. Combination therapy with GABA and GAD65, which is the active substance in Diamyd®, has been shown to act synergistically and prolong the survival of transplanted insulin producing beta cells in type 1 diabetes animal models (Tian et al. PLoS One 2011; 6(9):e25337). The Diamyd® diabetes vaccine is easily administered in any clinical setting and has been used in studies with more than 1000 diabetes patients. In a European Phase III study with children and adolescents recently diagnosed with type 1 diabetes, Diamyd® showed an overall 16% efficacy (p=0.10) versus placebo in preserving endogenous insulin secretion. The aim of combing treatment with Diamyd® and GABA is to test if this effect can be enhanced.
- Diamyd Medical’s current projects include development of another combination regimen for arresting the successive destruction of insulin producing beta cells using GAD65-based diabetes vaccine Diamyd® and Vitamin D with or without an anti-inflammatory compound.
Is
general: Yes
