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

Inclusion Criteria: 1. men and women 30-80 years of age inclusive; 2. type 2 diabetes mellitus diagnosed by a physician within 5 years prior to patient enrollment; 3. anti-diabetic drug regimen (either drug or dose of drug) unchanged during 8 weeks prior to screening and randomization; 4. HbA1C ≤ 9.5% on no oral hypoglycemic agents or HbA1C ≤ 8.0% on 1 oral agent or on half-maximal doses of 2 agents; 5. body mass index ≥ 23 kg/m2; 6. a negative pregnancy test and an agreement to use a reliable method of birth control for the duration of the trial in all females with childbearing potential; 7. ability and willingness to perform self-monitoring of capillary blood glucose (SMBG); ability and willingness to self-inject insulin; 8. provision of informed consent. 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.