Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study
Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study
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