InsuLine Medical's InsuPatch product has met the primary endpoint with an increase of insulin levels in the blood, during the first hour after injection.
The company said the statistical analysis of the trial results demonstrates significance of p<0.019 for this primary end-point, while the significance required by the FDA protocol was p<0.05.
InsuLine Medical CEO Ron Nagar said the analysis of the trial’s results will support its efforts to receive FDA approval of the InsuPatch.
"We are continuing the safety trials, which we hope to complete within the next few months," Nagar said.
"Immediately thereafter, we intend to register a request for FDA regulatory approval for the InsuPatch product."