Another randomized, double-blind Phase II and III clinical trial sponsored by Diasome Pharmaceuticals compared the reduction in mean glycated hemoglobin levels between two doses of oral HDV-I and placebo in patients with T2DM on background metformin therapy for 18 weeks post-treatment, along with several other parameters, such as fasting plasma glucose, insulin, and frequency of hypoglycemic events [75]. Here, INS is linked to type 2 diabetes mellitus.