30 month results from DIABGAD-1 support effect after partial remission phase
Results after 30 months of the investigator initiated pilot trial DIABGAD-1 show that treatment with the diabetes vaccine Diamyd® in combination with vitamin D and ibuprofen has a good safety profile and no serious related side effects. With the entire trial period taken into account, no significant difference in the ability to produce insulin was seen between the patient groups receiving active and placebo treatment. However, after the initial period, (partial remission phase or honeymoon period), a significant positive clinical effect was seen in the group receiving active treatment compared with placebo, and the effect was largest in the group reciving a double dose of Diamyd® plus vitamin D.
In the 30 month long pilot trial DIABGAD-1, the Diabetesvaccine Diamyd® is administered along with vitamin D and the anti-inflammatory substance ibuprofen. The trial has been conducted at nine pediatric diabetes clinics in Sweden with Professor Johnny Ludvigsson, Linköping University, as the principal investigator and sponsor. The aim has been to investigate the safety of the combination therapy in children and adolescents newly diagnosed with type 1-diabetes, and how the treatments affect the body’s own ability to produce insulin.
“Over the course of the entire trial period the diabetes vaccine, which in this trial was given subcutaneously in combination with vitamin D and ibuprofen, did not show an improvement in the effects of earlier studies with Diamyd®. The positive effect seen between 6 and 15 months has endured and has become significant at 30 months when looking at the difference in decline of the endogenous insulin-producing ability compared to placebo. This is really positive and something that we will further analyze in detail,” says Professor Johnny Ludvigsson at Linköping University, principal investigator of the trial.
Viewed over the entire 30 month trial period, no significant difference was seen between the placebo and the active groups, which all show a decrease in the ability to produce insulin (measured as C-peptide Area Under the Curve (AUC) in nmol/L). However, between 6 and 30 months (i.e. the partial remission phase, or honeymoon period), a significant difference in the decline of C-peptide AUC was seen between the groups receiving active and placebo treatment. Looking at the individual groups, those patients receiving a double dose of Diamyd® also declined significantly in the marker of blood sugar over time, HbA1c, compared to the placebo group between 6 and 30 months.
“These results provide further support for the positive effects and safety of Diamyd® in recent onset type 1-diabetic patients. It seems, however, that the observed effect in sustaining the endogenous insulin producing ability in newly diagnosed type 1-diabetes shown in DIABGAD-1 is limited, but can be significantly improved in the ongoing investigator-initiated DIAGNODE-1 trial, where the diabetes vaccine is administered directly into the lymph node, and preliminary results are very promising. In the light of this, our investment into our own clinical trial with intralymphatic injections of Diamyd® are spot on”, says Ulf Hannelius, CEO of Diamyd Medical.
The investigator-initiated pilot study DIABGAD trial has comprised approximately 60 patients between the ages of 10 and 18 newly diagnosed with type 1 diabetes, randomized to four treatment groups. The first group received one injection of Diamyd® 20µg on two occasions four weeks apart combined with ibuprofen over the course of 90 days, in addition to vitamin D for a period of 15 months; the second group received one injection of Diamyd® 20µg on two occasions four weeks apart combined with vitamin D for a period of 15 months; the third group received a double dose of Diamyd® four weeks apart and vitamin D for 15 months and; the fourth group received placebo only. Enrollment in the trial, which is double-blind, randomized and placebo-controlled, commenced in February 2013. The study ran at nine clinics in Sweden and is led by Professor Johnny Ludvigsson at Linköping University as the principal investigator and sponsor. All participants have now been monitored for the entire 30 months of the trial. The aim has been to investigate the safety of the combination therapy in children and adolescents newly diagnosed with type 1-diabetes and how the treatments affect the body’s own ability to produce insulin as measured by the release of C-peptide.
About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for diabetes and other serious inflammatory diseases through pharmaceutical development and investments in stem cell and medical technology.
Diamyd Medical develops the diabetes vaccine Diamyd®, an antigen-specific immunotherapy based on the exclusively licensed GAD-molecule. Five clinical studies are ongoing with Diamyd®. GABA constitutes alongside with the diabetes vaccine a key asset in Diamyd Medical and the Company uses its GABA in-licensed technology to develop a proprietary GABA drug product. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB. Diamyd Medical also has holdings in the medtech company Companion Medical, Inc., San Diego, USA and in the gene therapy company Periphagen, Inc., Pittsburgh, USA.
Diamyd Medical’s B-share is traded on Nasdaq First North under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.
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Ulf Hannelius, President and CEO
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Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
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This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16:00 CET on March 27 2017.