Clinical Research Directory

Inclusion Criteria: 1. Males and females, age 18 and ≤70 at time of screening visit 2. WOCBP must have negative serum or urine pregnancy test (min sensitivity 25 IU/L or equivalent HCG) within 24 hours prior to the start of the study 3. Women must not be breastfeeding 4. Inadequate BG control with Metformin defined as a screening HbA1c of ≥7.0 and ≤ 10.5 at the screening visit 5. Subjects should have been taking the same daily dose of Metformin for at least 8 weeks prior to the enrolment visit and subjects must not receive other antihyperglycemic medications within the 12 weeks prior to screening 6. FPG ≥140 mg/dL 7. BMI ≥28 and ≤40 8. Grade 1 hypertension defined as 140-159 systolic and 90-99 diastolic mmHg if patients is not receiving anti-hypertensive medication at the time of screening / or has never received anti-hypertensive medication. If patient is receiving anti-hypertensive medication at the time of screening and their BP is controlled, BP should be within the normal range of \<120-139 systolic and \<80-89 diastolic. Patients receiving anti-hypertensive medication at the time of screening and for which their hypertension is uncontrolled, will be excluded 9. eGFR ≥ 60 ml/min Exclusion Criteria: 1. Patients with Type 1 Diabetes 2. Patients with history of ketoacidosis 3. Subjects at serious risk of GI adverse events per the discretion of the study site investigator (e.g current or recent history of GI bleeding ulceration, or perforation) 4. Subjects with a planned radiologic study with IV contrast, surgery, or other planned procedures that may predispose them to metformin-associated lactic acidosis 5. Subjects with a history of uncontrolled hyperglycemia (\>15.0 mmol/L) after an overnight fast that required rescue therapy 6. Impaired kidney function defined as eGFR ≤60 mL/min 7. Subjects taking any prohibited medications. 8. Any of the following cardiovascular (CV)/vascular diseases within 3 months of the screening visit: 1. Myocardial infarction (MI) 2. Cardiac surgery or revascularization (coronary artery bypass surgery, Coronary Artery Bypass Graft \[(CABG\]/Percutaneous transluminal coronary angioplasty (PTCA)\] 3. Unstable angina 4. Unstable congestive heart failure (CHF) 5. Transient ischemic attack (TIA) or significant cerebrovascular disease 6. Unstable or previously diagnosed arrhythmia 7. Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute heart failure and/or known left ventricular ejection fraction of ≤40%. 8. Acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to the informed consent 9. Previous bariatric surgery 10. Previous bariatric surgery 11. Treatment with anti-obesity drugs within 3 months prior to screening visit 12. Subjects with COPD 13. Subjects with active liver disease 14. Subjects with active renal disease 15. Subjects with autoimmune diseases e.g. Lupus, Psoriasis 16. Subjects with HIV / AIDS 17. Subjects with Hematological and Oncological Diseases/Conditions 18. Haemoglobin \<11.0 g/dL (110 g/L) for men; haemoglobin \<10.0 g/dL (100 g/L) for women 19. Subjects with chronic disease e.g. Cancer, Epilepsy, Alzheimer, Parkinson 20. Subjects with abnormal free T4 21. Subjects with serious active infection