An Open Label Study Comparing Exenatide with Basal Insulin in Achieving an HbA1c of <_7.4% with Minimum Weight Gain, in Type 2 Diabetes Patients who are not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

INTERVENTION: Product Name: Exenatide Product Code: AC2993, LY2148568 Pharmaceutical Form: Solution for injection INN or Proposed INN: Exenatide CAS Number: 141732‐76‐5 Current Sponsor code: AC2993 (LY2148568) Other descriptive name: exendin‐4, exenatide Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.25‐ Product Name: Insulin Glargine Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin Glargine Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100‐ CONDITION: Type 2 Diabetes PRIMARY OUTCOME: Main Objective: The primary objective of this study is to determine whether exenatide given subcutaneously twice daily provides better HbA1c control, with minimal weight gain, than basal insulin given subcutaneously once daily for six months in patients with type 2 diabetes not adequately controlled using a combination of oral anti‐diabetic therapy and are a higher risk population (see section 4.1.1) as measured by the proportion of patients who have achieved HbA1c = 7.4% with minimal weight gain (= 1kg). Primary end point(s): The primary endpoint will be the proportion of patients achieving HbA1c = 7.4% with minimal weight gain (= 1kg). Secondary Objective: The secondary objectives of the study are to compare exenatide and insulin glargine with respect to:; •Proportion of patients who have achieved HbA1c = 7.4% and = 0.5kg weight gain; •Fasting serum glucose (FSG); •The proportion of patients achieving:; oHbA1c = 7.4% ; oHbA1c < 7% ; oHbA1c < 6.5% ; •7 point self monitoring blood glucose (SMBG) profile; •Changes in cardiovascular risk parameters:; oBMI (body mass index), waist circumference, waist/hip ratio. Weight change in kg and % plus the proportion of patients achieving 5% and 10% weight change.; oSystolic and diastolic BP (blood pressure).; oLipid profile.; •Hypoglycaemia rate per patient (adjusted for 30 days), incidence and severity; •Noctural hypoglycaemia; •Safety and Tolerability; •Patient reported Quality of Life; •Healthcare Resource Utilisation; INCLUSION CRITERIA: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Present with type 2 diabetes based on the disease diagnostic criteria, and are currently being treated with the following: Dual or triple oral therapy – on a stable combination and dose for at least 3 months. Patients will continue on their oral therapy. [2] HbA1c between 7.5% and 9.5%. [3] Present with any one of the cardiovascular risk factors as defined in Section 4.1.1. Disease Diagnostic Criteria. [4] BMI >27. [5] Are at least 30 years of age and less than 75 years of age. [6] Negative pregnancy test for women of childbearing potential (see exclusion criteria). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range