Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.

Primary objective :

To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.

Secondary objective :

• Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I DM.
• Recording adverse events.

Inclusion Criteria:

• Newly diagnosed type I diabetic patients
• Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
• BMI, 26-40 kg/m2
• HbA1c, 7.5%-10%
• Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
• FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)
• Willingness to accept, and ability to inject insulin Glargine therapy

Exclusion Criteria:

• Pregnancy : The use of LANTUS & APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population

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