Clinical Trials

Date: 2017-06-13

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the Diabetes Conference of the American Diabetes Associations (ADA) 77th Scientific Sessions

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:

Trial details:

• DiAPREV-IT is a double-blind, placebo-controlled Phase II study including a total of 50 children aged four and older who through analysis of diabetes markers, so-called auto-antibodies, in the blood are demonstrated to be at high risk of developing type 1 diabetes. Study participants have auto-antibodies against GAD65 and at least one other auto-antibody. Half of the children receive two injections of Diamyd®, and the remaining half receive placebo (inactive substance). The children will be monitored for a total of five years by means of sampling and glucose tolerance tests to evaluate the beta cell function, a measure of the body\'s own ability to regulate blood sugar. The purpose of the study  DiAPREV-IT is to evaluate whether preventive treatment with Diamyd® can delay or halt the progression of the disease so that the children do not develop clinical symptoms of type 1 diabetes.  Preventive treatment with Diamyd® is intended to intervene in the autoimmune process at an early stage, and thus prevent the disease from developing. The study is being conducted by a research group at Lund University and is led by Dr. Helena Elding Larsson, a pediatrician in Malmö and researcher at Lund University. The study is funded by research grants, but Diamyd Medical has participated in the design of the study and can utilize the study results. Five year results are expected during the first quarter of 2017.

Latest news:

• • On June 13, 2017, Diamyd Medical  announced final results from DiAPREV-IT 1, where the diabetes vaccine Diamyd® is given to a group of individuals at high risk of developing type 1 diabetes. Overall, the results show that the treatment was safe and tolerable, and that fewer subjects than expected, 16 out of 50 compared to expected 25 out of 50, had developed type 1 diabetes in the 5-year follow-up of the trial. However, no significant difference was seen between children receiving placebo and those who received the active substance. The trial results were presented by Associate Professor Elding Larsson at the Diabetes Conference of the American Diabetes Associations (ADA) 77th Scientific Sessions in San Diego, USA. "We saw good safety and the treatment did not negatively affect the children's insulin production. However, we could not prove that the treatment delayed or prevented children from developing type 1 diabetes," says Helena Elding Larsson, Principal investigator and Sponsor of the trial. “The trial is small and since fewer individuals than expected developed type 1 diabetes during the period, it may have affected the ability to detect differences in treatment effect. It is positive that the results show that Diamyd® is also safe to give to children who have not yet developed type 1 diabetes. We will now proceed to analyze the large amounts of mechanistic data collected over the years and to plan how we will follow up this trial.”
• No serious side effects were reported. Levels of GAD autoantibodies increased significantly (p = 0.0014) in those who received Diamyd® compared to placebo and remained elevated for up to 27 months after treatment, indicating that the treatment evokes an immunological response. The treatment did not affect the other beta cell autoantibodies, nor did it increase the prevalence of antibodies indicating other autoimmune diseases. No significant difference between the groups was observed regarding time to diagnosis.
• • On September 7, 2016, Diamyd Medical provided an update on clinical studies with Diamyd® for the treatment and prevention of type 1 diabetes.  In the placebo-controlled study DiAPREV IT-1, the last patient is expected to make its last visit in late 2016, where after the study results will be processed and analyzed before the results can be presented in the first quarter of 2017.
• • On February 17, 2014, the research group at Lund University, that runs DiAPREV-IT, a clinical study evaluating if the diabetes vaccine Diamyd® can prevent or delay the onset of type 1 diabetes in children at high risk of developing the disease, has applied to the Swedish Medical Products Agency to expand the study with an additional 50 children. The first part of the study, which also comprises 50 children, is fully recruited and results are expected in 2015. DiAPREV-IT, which was started in 2009, is a double-blind and placebo-controlled clinical study which to date has enrolled 50 children from four years of age. Half of the children have been treated with the diabetes vaccine Diamyd® and half with placebo (a non-active substance). The children are currently in follow-up and the first results of the study are expected in 2015.
• In addition to the DiAPREV-IT study described above, the enrollment of patients to another researcher initiated Phase II study with the diabetes vaccine Diamyd® is underway at around ten pediatric diabetes clinics across Sweden. In that study, called DIABGAD-1, children and adolescents recently diagnosed with type 1 diabetes are treated with the diabetes vaccine Diamyd® in combination with vitamin D and ibuprofen. That study aims to investigate whether the treatment can preserve the body’s capacity to make insulin. Some insulin producing capacity reduces the risk of both acute and long-term diabetes complications. The first results from DIABGAD-1 are expected to be presented in 2015.
• • On January 9, 2012, Diamyd Medical has announced that the prevention study with its diabetes vaccine is fully recruited. A total of 50 children aged four and older with a high risk of developing type 1 diabetes have been enrolled in this Phase II study, DiAPREV-IT, with Diamyd Medical’s diabetes vaccine Diamyd®. The study is thus fully recruited. The first results are expected to be compiled three years after the last participant is enrolled, and can thereby be presented in 2015. Diamyd® has previously been evaluated in a Phase III study of children already diagnosed with type 1 diabetes. The Phase III study did not met the primary efficacy endpoint of preserving beta cell function. Safety data from the study showed that Diamyd® was well tolerated, as demonstrated by a similar number of adverse events reported across all treatment groups.

Is general: Yes