Inclusion Criteria:

• Diagnosis of Type 2 diabetes mellitus for at least six months • 18 to 70 years of age, inclusive • A1c ≥ 7.5% and ≤ 10% • At least 3 months of continuous insulin and/or insulin analogues therapy (on at least 2 injections per day) +/- metformin prior to study entry • Negative Glutamic Acid Decarboxylase (GAD) autoantibodies • Ability and willingness to perform SMBG at least four times a day, and at least 7 times daily during the 7-point BG profile measurement days • Ability and willingness to adhere to and be compliant with the study protocol • Must be able to read English or Spanish at the sixth grade level in order to complete the patient-reported outcomes component of the study • Signed informed consent

Exclusion Criteria:

• Subjects treated with sulfonylureas, TZDs, or any other oral antidiabetic drugs (at study entry) except for insulin and/or insulin analogues with or without metformin • Planned pregnancy, pregnant or lactating females • For subjects treated with metformin - serum creatinine ≥ 1.5 mg/dL (133 µmol/L) for males or ≥ 1.4 mg/dL (124 µmol/L) for females • Serum creatinine ≥ 3.0 mg/dL (266 µmol/L) • Any clinically significant renal disease (other than proteinuria) or hepatic disease • Serum ALT or AST levels greater than 2.5 X the upper limit of normal • Any current malignancy or any cancer within the past 5 years (except adequately treated basal cell skin cancer or cervical carcinoma in situ) • Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study • Diagnosis of impaired dexterity or vision rendering the subject unable to administer MDI injections • Cardiac status NYHA III-IV • Hypersensitivity to Lantus or Apidra or any of its components • Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the completion of the study.

• Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study • Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol