Glycemic Optimization Treatment Study

Inclusion criteria

• Subjects must give their signed informed consent.
• Diagnosis of Type 2 DM for at least 6 months.
• Males and females greater than or equal to 18 years of age.
• A1c greater than or equal to 7.0%.
• Current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only.
• Demonstrated willingness and ability to inject insulin glargine.
• Able to understand and willing to comply with procedures required by the protocol and have access to a phone.
• Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG) and use of the algorithm calculator (AL-CAL).
• BMI greater than 25.0 kg/m2.
• Subjects who, in the opinion of the investigator, should be initiated on insulin therapy.

Exclusion criteria

• Cardiac status New York Heart Association (NYHA) III-IV (Appendix A).
• For subjects treated with metformin (Glucophager, Glucophage XRr, Glucovancer, Metaglipr , or Avandametr) plus a serum creatinine greater than 1.5 mg/dL (133 μmol/L) for males or greater than 1.4 mg/dL (124 μmoL) for females, the inability or unwillingness to discontinue these medications, and to remain off them through the entire study.
• For subjects on thiazolidinediones, the inability or unwillingness to discontinue these medications and to remain off them through the entire study.
• Planned pregnancy, pregnancy, or lactation.
• Serum creatinine greater than 3.0 mg/dL (266 μmol/L).
• Serum glutamic pyruvic transaminase (SGPT) greater than 2.5 x the upper limit of normal range.
• Any current malignancy or cancer within the past 5 years (except adequately treated basal cell carcinoma 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.
• Hypersensitivity to Lantus® insulin or any of its components.
• Any disease or condition, including the abuse of illicit drugs, prescription medicines, or alcohol that, in opinion of the sponsor/investigator, may interfere with the completion of the study.
• Current (last 2 months) insulin therapy.
• With the exception of thiazolidinediones (for all potential subjects) and for subjects who are taking metformin and have an exclusionary creatinine level, the ability or unwillingness to continue pre-study anti-hyperglycemia agents at pre-study dosages through the entire study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.