| Outcome Measures: |
Primary: Area under the curve of the endogenous glucose production from (=EGP) from begin of the hypoglycaemic clamp 5.5 mmol/L period until the end of recovery period (4.0 mmol/L), calculated from stable isotope labelled plasma glucose, After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198) | Secondary: Area under the curve of peripheral glucose uptake (=PGU), calculated from labelled PG from begin of the hypoglycaemic clamp period 5.5mmol/L until end of recovery period (4.0 mmol/L), After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)|Area under the glucose infusion rate curve from begin of the hypoglycaemic clamp period 5.5mmol/L until end of recovery period (4.0 mmol/L), After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)|Change in mean plasma glucagon concentrations from begin of the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase, After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)|Change in mean values of adrenaline from begin of the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase, After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)|Change in mean values of noradrenaline from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase, After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)|Change in mean values of cortisol from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase, After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)|Change in mean values of growth hormone from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase, After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)|Change in number of regulatory T-cells detected by blood (fasting) and measured by a laboratory, After 12 weeks and 2 days of treatment just before the hypoglycaemic clamp in each treatment period (day 86 and day 198)|Change in function of regulatory T-cells detected by blood (fasting) and measured by a laboratory, After 12 weeks and 2 days of treatment just before the hypoglycaemic clamp in each treatment period (day 86 and day 198)|Area under the glucose curve during the Mixed Meal Tolerance Test, Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)|Area under the c-peptid concentration curve during the Mixed Meal Tolerance Test, Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)|Area under the paracetamol concentration curve to calculate gastric emptying during the Mixed Meal Tolerance Test, Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)|Area under the insulin curve during the Mixed Meal Tolerance Test, Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)|Area under the glucagon curve during the Mixed Meal Tolerance Test, Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)|Change in HbA1c during each period detected by blood (fasting) at the begin of the visits and measured by a laboratory (tube: K3 EDTA Plasma), Period 1: Visit 2a (Day 1) versus at Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)|Change in fasting plasma glucose during each period detected by blood at the begin of the visits and measured by a laboratory (tube: lithium heparin plasma), Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197) | Other: Number of treatment emergent adverse events, From begin of the trial (Day 1) until the end of the trial (Day 204)|Number of self-reported hypoglycaemic episodes during each period, Day 1 until Day 86 (Period 1) compared with Day 113 until day 198 (Period 2)
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