EastGate Biotech Corp. announced positive Phase II Clinical Results of its innovative liquid insulin mouth rinse solution for Type 2 diabetes patients. The 90-day Phase II clinical study was conducted in Pakistan at the Sharif Medical City Hospital. Dr. Ayub Latif Khawaja is the Principal Investigator (PI). This ongoing Phase II human clinical trial is estimated to enroll 50 Type 2 patients currently on metformin treatment. Interim results are based on the first 30 patients who took a regiment of 25 IU of Insugin, a recombinant human liquid insulin mouth rinse twice a day at mealtime along with 500 mg of Metformin. The Phase II study assessed safety, tolerability, pharmacokinetics and efficacy. A placebo arm was also incorporated in the clinical protocol. The study summary and conclusions included: Insugin offers unique benefits and the product’s goal is to slow down progression of Type 2 diabetes mellitus and reduce complications; Insugin displayed a good safety and tolerability profile; Observed a statistically significant decrease in A1c levels after 1 week of treatment in combination with Metformin versus placebo; Observed that the most significant HbA1c reduction resulted from administration of a single dose of Insugin (25 IU) two times a day; Observed improvements in insulin secretion in Type 2 diabetes patients during hyperglycemic clamp; Observed that clinical efficacy of Insugin was non-inferior to Metformin, while its effect on HOMA-IR and fasting insulin level was superior compared to Metformin; Prevents the first step of apoptotic cascade (cytochrome C release) and protects cells from dying when submitted to an oxidative stress level (high glucose levels); Prevents endothelial dysfunction, which is well correlated to an improvement of atherosclerosis and cardiovascular complications; Preserves beta cell mass and beta cell function over time, leading to a potential delay of the disease’s progression.