CS02 vs Placebo With Metformin in Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria

• •1. Subjects with type 1 diabetes mellitus, secondary diabetes mellitus, or gestational diabetes;
• •2. Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma at Visit 1 or Visit 2;
• •3. Subjects with hypotension (average systolic pressure \< 90 mm Hg\*) at Visit 1 or Visit 2;
• •4. Subjects with cardiogenic shock within 8 weeks prior to Visit 1;
• •5. Subjects with sick sinus syndrome, second- or third-degree atrioventricular block (AV block);
• •6. Subjects with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes);
• •7. Subjects with recurrence or history of transient ischemic attack or coronary artery bypass surgery;
• •8. Subjects with history of cerebrovascular attack, myocardial infarction, serious cardiac disease (New York Heart Association NYHA Class III to IV), left ventricular ejection fraction≦40% within 12 weeks prior to Visit 1, or those with cardiovascular disease or cerebrovascular disease that may affect the administration of IP tablets (CS02) or its safety assessment in the opinion of the investigator or sub-investigator;
• •9. Female subjects who are nursing or pregnant during the study period;
• •10. Subjects are on a weight loss program and not in the maintenance phase or have started a weight loss medication including but not limited to Orlistat, Phentermine, Osymia, or Belviq or have undergone bariatric surgery within 8 weeks prior to Visit 1 or any type of surgery planned during the study;
• •11. Subjects with a clinically severe gastrointestinal disorder including diabetic gastroparesis; irritable bowel disease; recurrent episodes of nausea, vomiting, diarrhea and abdominal pain within 12 weeks prior to Visit 1;
• •12. Subjects have a history or current of substance or alcohol abuse;
• •13. Subjects have uncontrolled psychiatric disorder(s);
• •14. Subjects are less than 5 years free of malignancy (except for cured basal cell carcinoma of skin and cured carcinoma in situ of the uterine cervix);
• •15. Subjects have participated in another clinical trial within the last 12 weeks prior to Visit 1;
• •16. Subjects who are considered unreliable as to medication compliance or adherence to scheduled appointments, or inappropriate for inclusion per investigators, judgments;