Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus Subjects

Inclusion Criteria

• Male or female aged 35 to 60 years (both inclusive)
• Type 2 diabetes mellitus diagnosed 3 drinks per day or >14 drinks per week, or binge drinking).
• History of gastrointestinal disorders which may potentially interfere with absorption of the investigational product
• Treatment with systemic corticosteroids or with inhalational corticosteroids (Beclomethasone or budesonide) within the 3 months prior to enrolment
• Likelihood of requiring treatment during the study period with prohibited medications mentioned (as defined in this clinical trial protocol)
• Female subject who is pregnant, lactating or planning pregnancy during the trial
• Female subject of childbearing age who is not willing to use adequate method of contraception during the study period
• Life expectancy of less than 6 months from screening
• Elective surgery or any other surgical procedure/s requiring general anaesthesia during the clinical trial
• Has participated in another research trial within 12 weeks prior to screening
• History of diabetic ketoacidosis requiring hospitalization within 6 months prior to enrolment, case of proliferative retinopathy or advanced neuropathy
• Subject having any of the following laboratory results at screening
• Estimated glomerular filtration rate (eGFR) 3 times of upper limit normal
• Blood urea nitrogen (BUN) > 30 mg/dL
• Subject who has a positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections at screening
• Subject who has undergone pancreatectomy or pancreas islet transplant or renal transplant
• Subject receiving or has received any immunomodulation medications within 1 year prior to enrolment
• Subject with history or evidence of diabetic complications (e.g. diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy, etc.), cardiac disorders, or any other systemic complication due to diabetes, which in the opinion of the Investigator signifies subjects' ineligibility for the trial
• Has any concurrent disease or medical/surgical condition, which required treatment of more than 3 months and which in the opinion of the Investigator does not allow participation of the subject in this study