Insulin Glulisine in Type 2 Diabetic Patients

Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-month Proof of Concept Study.

To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.

Inclusion Criteria:

• Diabetes Mellitus, Type 2
• 25 < BMI < 45 kg/m²
• 7,5% < HbA1c < 9%
• Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months

Exclusion Criteria:

• Type 1 diabetes mellitus
• Treatment with OADs only
• Treatment with thiazolidinediones, with exenatide or with pramlintide
• Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
• Active proliferative diabetic retinopathy,
• 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 drugs or to drugs with a similar chemical structure.
• Treatment with systemic corticosteroids in the 3 months prior to study entry
• Treatment with any investigational product in the 2 months prior to study entry
• Previous treatment with insulin glulisine
• 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
• Impaired renal function
• History of drug or alcohol abuse

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