Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2)

Inclusion criteria

• Diabetes type 2
• Patients treated NPH insulin with stable dosage of OADs (Oral antidiabetic drugs) for at least 2 months prior to study start and OADs treatment with metformin at least 1,7 g /day in combination with sulfonylurea or glinides.
• Patients must have a HbA1c range of >= 4,5% ( 6,2% DCCT/Diabetes Control and Complication Trials) and <= 8% ( 9,4 % DCCT/Diabetes Control and Complication Trials)
• Ability and willingness to perform continuous glucose monitoring system / CGMS (examination within the study)
• Written informed consent obtained prior to enrollment in the study
• Women are either not of childbearing potential or women of childbearing potential must not be pregnant and must use a reliable contraceptive measure for the duration of the study

Exclusion criteria

• Fasting value C peptide <= 400 pmol/l
• 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.
• Pregnant women or women planning gravidity during clinical study protocol
• Breast-feeding
• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
• Treatment with systemic corticosteroids in the 3 months prior to study entry and during study and other treatment, that can significantly have impression to glycaemia.
• 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 Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
• Impaired renal function as shown by serum creatinine >/= 133 micromol/L in men and >/= 124 micromol/L in women at study entry
• History of drug or alcohol abuse in the last year
• Mental condition causing the patient unable to understand the nature, scope and possible consequences of the study
• Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
• Use of insulin glargine outside the scope of the current SPC (Summary of Product Characteristics)

• Patients included in other clinical studies

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.