Opposing Step-by-step Insulin Reinforcement to Intensified Strategy

You may not qualify if:

• Type 1 diabetes mellitus
• Treatment with OADs only
• Treatment with thiazolidinediones
• Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
• Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed in the 2 years prior study entry)
• Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
• Breast-feeding
• History of hypersensitivity to the study drug or to drugs with a similar chemical structure or to insulin glargine
• Treatment with systemic corticosteroids, irrespective of the dose of administration and irrespective of the prior or foreseeable treatment duration
• Treatment with any investigational product in the last 2 months before study entry, except for insulin glargine
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
• Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at study entry
• Impaired renal function as shown by serum creatinine \>135 μmol/l in men and \> 110 μmol/l in women at study entry
• History of drug or alcohol abuse
• +5 more criteria