Effects and comparisons of once & twice daily insulin’s in combination with oral hypoglycaemic agents on glycaemic control, hypoglycaemia and weight in type 2 Diabetes.

INTERVENTION: Trade Name: Lantus Product Name: Lantus Pharmaceutical Form: Injection* Trade Name: Levemir Product Name: Levemir Pharmaceutical Form: Injection* Trade Name: NovoMix Product Name: Novomix 30 Pharmaceutical Form: Injection* CONDITION: Type 2 Diabetes ; MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus PRIMARY OUTCOME: Main Objective: To determine and identify the most optimum insulin and oral hypoglycaemic agent combination to achieve maximum glycaemic control with the least hypoglycaemic events and little or no weight gain and even possible weight reduction. Primary end point(s): a. HbA1c.; b. Fasting plasma glucose.; c. 8 point blood glucose profile (pre‐ and 2 hours postprandial blood glucose measurements and at bedtime and at 0300 h).; d. Daily blood glucose variability assessed by patient’s blood glucose monitoring diary.; Secondary Objective: To determine the effects of Insulin in combination with oral hypoglycaemic agents on glycaemic control, weight and hypoglycaemic events in poorly controlled type 2 Diabetes patients. INCLUSION CRITERIA: 1. Patients with Type 2 Diabetes Mellitus: a. Insulin naïve. b. Men or Women. c. Age between 40‐80 years. d. Duration of diabetes of at least 3 years. 2. HbA1c > 7.5%. 3. On maximum tolerated combination oral hypoglycaemic agents for more than 6 months. 4. BMI > 25. 5. All patients clinically requiring the commencement of insulin therapy. 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