| Outcome Measures: |
Primary: Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment, after 24 weeks of treatment | Secondary: Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment, after 52 weeks of treatment|Fasting Plasma Glucose After 24 Weeks of Treatment, after 24 weeks of treatment|Fasting Plasma Glucose After 52 Weeks of Treatment, after 52 weeks of treatment|Postprandial Glucose AUC After 24 Weeks of Treatment, Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment, after 24 weeks of treatment|Postprandial Glucose AUC After 52 Weeks of Treatment, Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment, after 52 weeks of treatment|Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment, Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime., after 24 weeks of treatment|Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment, 7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime., after 52 weeks of treatment|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment, Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime., after 24 weeks of treatment|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment, Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime., after 52 weeks of treatment|Body Weight After 24 Weeks of Treatment, after 24 weeks of treatment|Body Weight After 52 Weeks of Treatment, after 52 weeks of treatment|Hypoglycaemic Episodes, Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., over 52 weeks of treatment
|
