| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin (HbA1c) at Month 7, week 0, month 7 | Secondary: Change in Glycosylated Haemoglobin (HbA1c) at Month 4, week 0, month 4|Change in Mean Fasting Plasma Glucose (FPG) at Month 7, week 0, month 7|Change in Mean Fasting Plasma Glucose (FPG) at Month 4, week 0, month 4|Change in Mean Pre-lunch Plasma Glucose at Month 7, week 0, month 7|Change in Mean Pre-lunch Plasma Glucose at Month 4, week 0, month 4|Change in Mean Pre-dinner Plasma Glucose at Month 7, week 0, month 7|Change in Mean Pre-dinner Plasma Glucose at Month 4, week 0, month 4|Change in Body Weight at Month 7, week 0, month 7|Change in Body Weight at Month 4, week 0, month 4|Mean Number of Total Hypoglycaemic Episodes, Month 1, Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period., weeks -2-0, month 1|Mean Number of Total Hypoglycaemic Episodes, Months 2-4, Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period., weeks -2-0, months 2-4|Mean Number of Total Hypoglycaemic Episodes, Months 5-7, Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period., weeks -2-0, months 5-7
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