Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus

Exclusion Criteria

• •Insulin use within the previous year
• •History of hypoglycemia unawareness
• •Acute or chronic, or history of, metabolic acidosis, including diabetic ketoacidosis
• •Impaired renal function as shown by, but not limited to, serum creatinine ≥ 3mg/dL. For subjects taking metformin, serum creatinine \>/= 1.5 mg/dL for males, or \>/= 1.4 mg/dL for females.
• •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN)
• •Clinically significant peripheral edema if subject is using a TZD
• •History of stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the past 12 months
• •History of, or current, congestive heart failure (New York Heart Association \[NYHA\] III-IV) requiring pharmacologic treatment
• •Acute infection
• •Any malignancy within the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma or adequately treated cervical carcinoma in situ
• •Current substance addiction or alcohol abuse or history of substance or alcohol abuse, within the past 2 years
• •Any clinically significant renal disease (other than proteinuria) or hepatic disease
• •Pregnant or lactating females
• •Dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• •Impaired dexterity or vision rendering the subject unable to administer injections
• •Known hypersensitivity to insulin glargine or insulin glulisine or any of the components of Lantus or Apidra
• •Any disease or condition (including abuse of illicit drugs, prescription medications, or alcohol) that, in the opinion of the investigator or sponsor, may interfere with the completion of the study
• •Unlikely to comply with the protocol, eg, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete 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
• •No subject will be allowed to enroll in this study more than once.