Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin

Inclusion criteria

• Diagnosis of type 2 diabetes mellitus for at least six months; 18 to 70 years of age, inclusive.
• A1c ≥ 7.0% and ≤ 10% at screening
• At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections) +/- metformin prior to study entry. (Note: Subjects receiving insulin glargine [Lantus] twice a day [split dose] will be considered as being on one injection only.)
• Willingness of subject to discontinue other anti-diabetic drug treatments and to remain off them through the entire study
• Negative glutamic acid decarboxylase (GAD) autoantibodies
• Ability and willingness to perform self-monitoring of blood glucose (SMBG) at least four times a day, and at least 7 times daily during the 7-point blood glucose (BG) profile measurement days
• Ability and willingness to adhere to, and be compliant with, the study protocol
• Must be able to read English 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, thiazolidinediones (TZDs), or any other oral antidiabetic drugs (within the 3 months before 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) 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 insulin glulisine (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.