Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)

Primary:

• To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
• To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.

Secondary:

• To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

Inclusion Criteria:

• Type 1 or type 2 diabetic patients
• Measure HbA1c 6.5% to 11.0% at visit 1
• More than 3 months of continuous insulin treatment immediately prior to study entry

Exclusion Criteria:

• Pregnant women

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