InsuLine Medical Ltd. (TASE: INSL) announced positive results in efficacy and safety in a clinical trial of its insulin patch, InsuPatch for the treatment of Type 1 (juvenile) diabetes. The InsuPatch met its primary endpoint for obtaining US Food and Drug Administration (FDA) approval of the product.
The InsuPatch achieved a relative median increase of 29.7% in insulin levels in the blood within an hour compared with an insulin injection without the product. The FDA requirement was a median increase of at least 10%.
Fifty five patients participated in the clinical trial, and the analysis was conduction on the 51 patients who met the FDA protocols for the trial.
One hundred patients are participating in the second part of the trial to test InsuPatch’s safety. The trial, which began early in 2011, is due to be completed in April 2012. Following the completion of the trial and analysis of the results, InsuLine will submit a certification application for the product with the FDA.
Insuline’s technology enables faster insulin absorption by increasing local blood perfusion at the injection site which enables faster clearance of the insulin