Effects of EXEnatide on Glycemic Control and Weight over 26 weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients with Type 2 Diabetes :

INTERVENTION: Trade Name: BYETTA Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Type 2 diabetes mellitus ; MedDRA version: 12.0 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus PRIMARY OUTCOME: Main Objective: Change from baseline to 6 months of centrally measured HbA1c Primary end point(s): The primary objective is to estimate the difference in change in HbA1c from baseline to treatment endpoint (26 weeks) between exenatide versus placebo in type 2 diabetes patients uncontrolled by CSII (HbA1c between 7.5 to 10%). Secondary Objective: Change from baseline in weight, BMI, waist circumference, 6 points glucose profile, insulin doses, % of daily use of insulin as basal rate, % of daily use of insulin as bolus, quality of life questionnaire.In addition, secondary endpoints based on CGMS recordings performed in centers participating to the ancillary study : Change from baseline in mean blood glucose value, occurrence of hyperglycemia above 190 mg/dl expressed as Area under the Curve (high) above 190 mg/dl (10.5 mmol/l), occurrence of hypoglycemia below 70 mg/dl (3.9 mmol/l) expressed as Area Under the Curve (low) below 70 mg/dl, glycemic variability (MAGE index) INCLUSION CRITERIA: Men or women aged 35 to 70 Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2‐hour post‐prandial or random glucose >200 mg/dL) or fasting plasma glucose elevation on more than 1 occasion > 125 mg/dL or patient currently undergoing pharmacological and/or non‐pharmacological treatment for diabetes mellitusCSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c > 8 % despite a well‐conducted MDI trial using a 2 to 5 daily injection regimen)HbA1c = 7,5% and = 10 %BMI = 25 and = 45Stable body weight (=10% variation) during the last 3 months. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18‐64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for