Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)

Exclusion Criteria

• •1. current use of insulin;
• •2. history of hypoglycemia unawareness; history of severe hypoglycemia requiring assistance within the last 5 years;
• •3. renal dysfunction as evidenced by serum creatinine (Cr) ≥ 124 μmol/l;
• •4. history of lactic acidosis or diabetic ketoacidosis;
• •5. active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times upper limit of normal at the time of enrollment;
• •6. history of pancreatitis;
• •7. cardiovascular disease including any of: a) systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 105 mmHg; b) peripheral vascular disease; c) left bundle branch block or second or third degree AV block; d) tachyarrhythmias or bradyarrhythmias with uncontrolled ventricular rate; e) stenotic valvular heart disease; f) cardiomyopathy; g) history of heart failure; h) history of aortic dissection; i) documented history of angina or coronary artery disease; j) history of stroke or transient ischemic attack;
• •8. history of any disease requiring continuous systemic glucocorticoid treatment;
• •9. history of any major illness with a life expectancy of \< 3 years;
• •10. history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity;
• •11. excessive alcohol consumption (\>14 alcoholic drinks per week in men and \>7 alcoholic drinks per week in women);
• •12. known hypersensitivity to insulin glargine, metformin, or any DPP-4 inhibitor.