Diamyd Medical announced its European phase IIb trial of the diabetes vaccine Diamyd® is close to being fully enrolled.
The phase IIb trial, dubbed DIAGNODE-2, is a follow-up trial based on a smaller investigator-initiated pilot trial, DIAGNODE-1, where results showed that 11 out of 12 patients recently diagnosed with Type 1 diabetes are in a so-called “honeymoon period,” also called partial remission, 15 months after the start of the trial.
In the trail, the diabetes vaccine Diamyd® is given directly into the lymph node with the aim to preserve the patients’ endogenous insulin production.
Partial remission in Type 1 diabetes is characterized by low external insulin requirement and near to normal long-term blood sugar levels.
The results also show an effect on preserving the patients’ endogenous insulin production, measured as stimulated C-peptid.
By maintaining the endogenous insulin production there is a potential to make a significant difference in the daily life of patients as well as to reduce the complications of Type 1 diabetes.
“We have high expectations on DIAGNODE-2 given the very promising 15-month results from the pilot trial DIAGNODE-1”, says Ulf Hannelius, CEO of Diamyd Medical in a statement. “Final screening activities are ongoing to wrap up patient enrollment during the spring.”
How does the vaccine work?
Type 1 diabetes is an autoimmune disease where the beta cells, the cells in the pancreas that produce insulin, are destroyed by the immune system.
GAD65 (glutamic acid decarboxylase) is an endogenous protein that is expressed by the beta cells.
In Type 1 diabetes, the immune system identifies the protein as dangerous and attacks and destroys the insulin-producing cells.
GAD65 is the active ingredient in the diabetes vaccine Diamyd® which is being developed with the aim to reduce the immune system’s sensitivity to GAD65 and thus preserving the remaining insulin production.
- European Phase IIb Trial in Type 1 Diabetes With the Diabetes Vaccine Diamyd® Close to Being Fully Recruited. (2019, March). Retrieved: https://prnmedia.prnewswire.com/news-releases/european-phase-iib-trial-in-type-1-diabetes-with-the-diabetes-vaccine-diamyd-r-close-to-being-fully-recruited-819875157.html