Insulin Glargine in Type 2 Diabetes Mellitus

Exclusion Criteria

• •Treatment with any insulin in the last 4 weeks prior to study entry
• •Diabetes mellitus following pancreatectomy
• •GAD positive (glutamic acid decarboxylase)
• •Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which may require surgical treatment within 3 months of study entry
• •Pregnant or breast-feeding
• •Women of childbearing potential who did not take adequate contraceptive protection such as systemic hormones (birth control pills, implant), intrauterine device, or a barrier method (diaphragm with intravaginal spermicidal, cervical cap, male or female condom)
• •History of hypersensitivity to the study medication or to drugs with similar chemical structures
• •Treatment with any investigational drug in the last 3 months before study entry
• •Previous enrollment in a study involving HOE901 insulin analogue
• •Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. non-cardio selective beta-blockers, systemic corticosteroids)
• •Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematological or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
• •History of drug or alcohol abuse
• •Impaired hepatic function, as shown by, but not limited to,alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) above 3x the upper limit of normal, if no lower values are required by the individually administered OAD
• •Impaired renal function, as shown by, but not limited to, serum creatinine \> 177 mmol/l (\> 2 mg/dl), if no lower values are required by the individually administered OAD
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.