Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus

Inclusion Criteria: * Male and female adult patient of 18-65 years with uncontrolled type 2 diabetes Mellitus (T2DM). * Patients with HbA1c ≥ 7 to 10 and those on oral hypoglycemic agents ≤ 2 other than Insulin and Gliptins. * BMI in the range of 18.5 - 35 kg/m2. * All patients must be willing to give informed consent and can understand \& complying protocol requirement. * Patients who are in good health at the time of entry into the study as determined by medical, medication and hypersensitivity histories, clinical examination, vital sign measurements, chest X-ray, 12-lead ECG measurement and clinical judgment of the investigator. * Documented negative test for human immuno virus (HIV), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV). Exclusion Criteria: * Those who are on insulin and not ready for wash out of 3 months. * Those who are on gliptin and not ready for wash out of 3 months. * Those with a history of severe ketosis, diabetic coma or pre-coma, or type 1 diabetes. * Those scheduled for or who had undergone surgery. * Those with a severe infection or serious injury * Pregnant and lactating women. * Hypersensitivity and contraindication to DPP-IV inhibitors or excipients of investigational drug formulation. * Hypertensive patients with blood pressure ≥160/100 mm of Hg. * History of ischemic heart disease (as evident from ECG), stroke and/or transient ischemic attack. * Debilitating neurological or psychiatric disorders * History or currently consuming abusing drugs or alcohol. * Serious hepatic or renal impairment (liver dysfunction as evidenced by SGPT/SGOT level of 2.5 X ULN and renal dysfunction as evidenced by creatinine level 2.5 X ULN). * Patient with abnormal clinical chemistry, hematology or urinalysis results that are considered clinically significant by the investigator or the sponsor. * Patient has any concurrent illness which, in the opinion of the investigator or coinvestigator, may interfere with treatment or evaluation of safety or completion of this study. * In the investigator's judgment, the patient is unable to adhere to the treatment regimen, protocol procedures or study requirements. * Participation in another clinical trial in the past 3 months. * Patients with history of smoking or currently having smoking habit will not be included in the study.