baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

Phase IV, Multicenter, International, Non-comparative, Open Label Study of Efficacy and Safety of Basal Bolus Therapy (Insulin Glargine + Insulin Glulisine) in Patients With T1 Diabetes Previously Uncontrolled on Any Insulin Regimen.

Primary Objective:

To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM).

Secondary Objectives:

To evaluate:

• The change of hemoglobin A1c (HbA1c) from baseline to week 12
• The percentage of patients with HbA1c < 7% at week 12 and week 24
• The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24
• The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24
• The incidence of symptomatic hypoglycemias
• Adverse events

After a two-week run-in period patients will enter a six-month treatment period.

Estimated study duration per patient : 26 weeks (including a 2-week run-in period).

Inclusion criteria:

1. Known Type 1 diabetic patients (male or female) treated with any type of insulin regimen, except:

   • continuous subcutaneous insulin infusion (CSII, or pump), and
   • patients already treated with insulin glargine

2. Age: 18-60 years inclusive

3. HbA1c: 8% - 10% assessed over the past 6 month

4. At least 1 year of continuous insulin treatment

5. Willingness to accept, and ability to follow:

   • a basal bolus regimen (glargine x1 and glulisine x3 per day),
   • self-monitoring blood glucose (SMBG)
   • a fixed meal plan, or CHO counting

6. Signed informed consent obtained prior to any study procedure

Criteria for entry in the treatment period:

1. HbA1c 8-10% assessed between week -2 and week 0
2. Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women
3. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal
4. Pregnancy test negative if women of childbearing potential

Exclusion criteria:

1. History of hypersensitivity to insulin glargine and/or insulin glulisine
2. Pregnant, breast-feeding or women of childbearing potential not using efficient contraception
3. Brittle diabetes
4. Known impaired renal function defined as serum creatinine > 135 micromol/L in men and > 110 micromol/L in women at study entry
5. Known impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal at study entry
6. Diabetes ketoacidosis
7. History of drug or alcohol abuse
8. Psychiatric or mental disease
9. Inclusion in another study in the past 6 months or previous inclusion in this study
10. Patient unable or unwilling to manage properly the basal bolus regimen

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