| Outcome Measures: |
Primary: Frequency of subjects with HbA1c: ≤ 6.5 %, 6.5 %< HbA1c ≤ 7.0 %, 7.0 %<HbA1c ≤ 8.0 % and HbA1c > 8.0 %, at endpoint | Secondary: Change in fasting blood glucose, (FBG), baseline to endpoint|Frequency of subjects with: FBG ≤ 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG ≤ 126 mg/dl(7.0 mmol/l) and FBG > 126 mg/dl (7.0 mmol/l), at endpoint|Change in nocturnal blood glucose, baseline to endpoint|Change in fasting plasma glucose, baseline to endpoint and all visits|Change in mean daytime blood glucose, baseline to endpoint|Change in mean daily blood glucose, baseline to endpoint|Change in blood glucose at the remaining time points of the 8-point-blood glucose profiles, baseline to endpoint|Frequency of subjects with hypoglycemic events (overall, severe, nocturnal, symptomatic), from the inform consent signature to the end of the study
|
