Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus

Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine

Primary Objective:

To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients

Secondary Objective:

To evaluate the insulin glulisine doses To assess the patient satisfaction

Inclusion Criteria:

• Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
• 6.5 <=HbA1c <= 11% at visit 1
• BMI <35 kg/m²
• Provision of signed and dated informed consent prior to any study procedures
• Ability and willingness to complete study diaries and questionnaires
• Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
• A negative pregnancy test for all females of childbearing potential.

Exclusion criteria:

• Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
• Pregnant women
• Active proliferative diabetic retinopathy
• Impaired hepatic or renal function

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