Oral Insulin study for Type 2 Diabetes Mellitus

INTERVENTION: Intervention1: Oral Insulin: 16mg(2capsules)insulin/day at bed time, treatment for 6 weeks, total enrollment period 8 weeks Control Intervention1: Placebo: Placebo at bed time, treatment for 6 weeks, total enrollment period 8 weeks, CONDITION: Diabetes Mellitus Type 2 PRIMARY OUTCOME: Tolerability of oral insulin‐‐‐‐‐‐Timepoint: Treatment period of 6 weeks SECONDARY OUTCOME: 1. The secondary objective of this study is to compare the changes in levels of fasting glucose, c‐peptide and insulin in two groups of subjects with Type 2 Diabetes Mellitus currently on diet alone or diet with a monotherapy consisting of Metformin of up to 2.5 g/day; one group of subjects will receive an oral insulin capsule once daily and another group of subjects will receive a placebo once daily.; 2 To compare the change in fasting plasma glucose (FPG) values, as well as; fructosamine and HbA1c in subjects who have been treated with oral insulin; or placebo.; 3.To evaluate the plasma levels of insulin as well as the C‐Peptide levels in subjects that has been treated with oral insulin or placebo.‐‐‐‐‐‐Timepoint: 6 weeks INCLUSION CRITERIA: 1. Male or Female subjects aged 20 to 60 years inclusive. 2. FBG ≥130 to ≤ 200 mg/dl 3. Confirmed diagnosis of Type 2 diabetes as defined by WHO criteria (fasting venous plasma glucose concentration ≥ 7.0 mmol/L or 2‐h post‐glucose load venous plasma glucose ≥ 11.1 mmol/L) treated with diet alone or diet and Metformin (up to 2.5 g/day) (any type and regimen) for at least three months with HbA1c 7.5% ≥ 10.5% at screening Visit. 4. BMI ≤ 33 5. Generally in good health, as evidenced by lack of significant findings in medical history, physical examination, clinical laboratory tests, vital signs, and ECG. 6. Able to understand and sign the written informed consent and be willing to follow the protocol requirements.