Clinical trials

DEDICATED TO FINDING A CURE

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

Clinical Trials

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

Research

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

Clinical Research

Patient meeting with clinical study investigator

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.

CLINICAL TRIALS WITH DIAMYD^®

DIAGNODE-2

ClinicalTrials.gov

COORDINATING INVESTIGATOR
Professor Johnny Ludvigsson
Linköping University, Sweden

A double-blind, placebo-controlled intervention trial, where Diamyd^® (GAD-alum) is administrated directly into lymph nodes in combination with vitamin D. The trial evaluates the effectiveness of preserving the insulin producing capacity.

INVESTIGATOR-INITIATED CLINICAL TRIALS

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

DIAGNODE-1

ClinicalTrials.gov

PRINCIPAL INVESTIGATOR
Professor Johnny Ludvigsson
Linköping University, 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.

DiAPREV-IT 2

ClinicalTrials.gov

PRINCIPAL INVESTIGATOR
Dr. Helena Elding Larsson
Lund University, 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.

EDCR IIa

ClinicalTrials.gov

PRINCIPAL INVESTIGATOR
Professor Johnny Ludvigsson
Linköping University, 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.

GABA/DIAMYD^®

ClinicalTrials.gov

PRINCIPAL INVESTIGATOR
Professor Kenneth McCormick
University of Alabama at Birmingham, 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.

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) and meta-analysis of previously published clinical studies support the positive effect of the diabetes vaccine Diamyd^® by reducing the loss of C-peptide (Diabetologia 2016; 10.1007/s00125-016-4122-1).

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.

DEDICATED TO FINDING A CURE

Clinical Trials

Research