DEDICATED TO FINDING A CURE

The way forward is to downregulate inflammation, induce tolerance and recover beta cell function

 

Clinical Trials

Six clinical trials are ongoing combining the diabetes vaccine Diamyd® with various other immunomodulatory compounds including GABA

Research

Research with GAD, GABA and Gliadin for the treatment, prevention or cure of autoimmune diabetes is ongoing, both in preclinical and clinical phases

Combination Therapies

Diamyd Medical develops combination therapies for the treatment of autoimmune diabetes with the objective of preventing, delaying or stopping the autoimmune attack on beta cells and thus preserve the body’s own ability to produce insulin. The clinical research includes development of combination regimens including the GAD-based Antigen Based Therapy Diamyd® and other compounds such as anti-inflammatory and immunosuppressing substances, including GABA, both in terms of preventing and intervening in type 1 diabetes. By combining various substances with different mechanisms of actions, e.g. decreasing inflammation, suppressing the immune system, strengthening the beta cells and inducing tolerance, the disease is tackled on several fronts.

Ongoing Clinical Trials with Diamyd®

Six investigator-initiated clinical trials with Diamyd® in different treatment regimens, including GABA, are ongoing. Four combination studies aim to intervene in the autoimmune type 1 diabetes process and two interception studies aim to prevent type 1 diabetes diagnosis in children at very high risk of developing the disease.

DIABGAD-1
PRINCIPAL INVESTIGATOR
Professor Johnny Ludvigsson
 Linköpings universitet, Sweden

A placebo-controlled intervention trial, where Diamyd® is combined with ibuprofen and vitamin D in patients recently diagnosed with type 1 diabetes. The aim of the combination treatment is to preserve the body’s own capacity to produce insulin.


GABA/DIAMYD®
PRINCIPAL INVESTIGATOR
Alexandra Martin, MD
 University of Alabama, USA

A placebo-controlled intervention trial where Diamyd® is combined with GABA. The aim of the combination treatment is to preserve the body’s residual capacity to produce insulin.


DIAGNODE-1
PRINCIPAL INVESTIGATOR
Professor Johnny Ludvigsson
 Linköpings universitet, Sweden

An open label intervention trial, where Diamyd® is administrated directly into lymph nodes in combination with vitamin D. The aim of the trial is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity.


EDCR IIa
PRINCIPAL INVESTIGATOR
Professor Johnny Ludvigsson
 Linköpings universitet, Sweden

An open label intervention trial where Diamyd® is combined with etanercept and vitamin D. The aim of the trial is to evaluate the safety of the combination treatment and the effect on the immune system and the patient’s insulin producing capacity.


DiAPREV-IT 1
PRINCIPAL INVESTIGATOR
Dr. Helena Elding Larsson
 Lunds universitet, Sweden

A placebo-controlled prevention trial where Diamyd® is administered to children at high risk of developing type 1 diabetes, meaning that they have an ongoing autoimmune process but not yet any clinical symptoms of diabetes. The aim of the trial is to evaluate whether Diamyd® can delay or prevent the participants from presenting with type 1 diabetes.


DiAPREV-IT 2
PRINCIPAL INVESTIGATOR
Dr. Helena Elding Larsson
 Lunds universitet, Sweden

A placebo-controlled prevention trial where Diamyd®, in combination with vitamin D, is administered to children at high risk of developing type 1 diabetes, meaning that they have an ongoing autoimmune process but not yet any clinical symptoms of diabetes. The aim of the trial is to evaluate whether Diamyd® can delay or prevent the participants from presenting with type 1 diabetes.


 

GOOD SAFETY PROFILE

Diamyd® has been administered to more than 1,000 patients in clinical trials and has presented a good safety profile

 

Clinical Research Publications

The diabetes vaccine Diamyd® has been evaluated in a global Phase III program in Europe and the USA, including more than 660 recent-onset type 1 diabetes children. The program was conducted in collaboration with the US pharmaceutical giant Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI). Results from the European study showed clinical effect in several subgroups and a limited overall 16 percent efficacy (p=0.10) in beta cell preservation (N Engl J Med 2012;366:433-442).

Simultaneously, the research consortium Type 1 Diabetes TrialNet conducted a Phase II study in children and adults (Lancet 2011;378:319-327). The studies did not reach their primary efficacy parameters of preserving beta cell function and the Company decided not to complete the Phase III program, but have continued the clinical development of Diamyd® based on positive findings from the results. The Phase III program was based on positive results from a Phase II study in children with type 1 diabetes (N Engl J Med 2008;359:1909-1920). Additionally, a placebo-controlled Phase II study in adult LADA patients has been conducted comparing the efficacy of different Diamyd® doses (Diabetologia 2009;52:1363-1368).

The ongoing investigator-initiated clinical trials and previous findings from Phase II and Phase III studies in children and young adults are leading us to a better understanding of how to prevent, treat or cure type 1 diabetes.