TOFO Insulin Combination Trial

Inclusion criteria: * Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM). * Hemoglobin A1c ≥7.5% - ≤10.5% and FPG ≤220 mg/dL. * Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening. * Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening. * Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen. * Body mass index (BMI) ≥18.5 kg/m\^2 and \<35.0 kg/m\^2. * No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening. Exclusion criteria: * Type 1 diabetes mellitus. * Pregnancy or lactation. * Severely uncontrolled glycemic situation. * History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening. * History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months. * A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of the reference range at the central laboratory test facility. * Has previously received treatment with the investigational product. * Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment. * Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical \[skin\] application, eye drops and sprays). * Patients who are frequently experiencing orthostatic hypotension. * Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment: * Lipid-lowering drug * Antihypertensive drug * Thyroid hormone preparation * Uric acid lowering drug The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.