Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin

Exclusion Criteria

• •Subjects treated with sulfonylureas, thiazolidinediones (TZDs), or any other oral antidiabetic drugs (at study entry) except for insulin and/or insulin analogues with or without metformin
• •Planned pregnancy; or 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 for 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 multiple daily injections (MDIs)
• •Cardiac status New York Heart Association (NYHA) III-IV
• •Hypersensitivity to Lantus or Apidra or any of their 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