Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement

Primary objective: Difference in frequency of subjects with conventionally detected hypoglycemia by the subject \[at least one measurement smaller/equal 60mg/dl documented in the 8-point profile in the case record form (CRF) or documentation of symptomatic hypoglycemia in the CRF through Visits 8/9\] compared to CGMS detected blood glucose values smaller/equal 60mg/dl during CGMS measurements (at least one measurement through Visits 8/9) after eight weeks of treatment with insulin glargine. Secondary objective: Secondary study objectives were to investigate the safety and efficacy of a treatment change to insulin glargine in ICT treated subjects in terms of:

• Percentage of blood glucose measurements(CGMS data)smaller/equal 60mg/dl \[3.3 mmol/l\].
• Percentage of nocturnal blood glucose measurements(CGMS data)smaller/equal 60mg/dl\[3.3 mmol/l\].
• Percentage of daytime blood glucose measurements(CGMS data)smaller/equal 60mg/dl\[3.3 mmol/l\].
• Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose smaller/equal 60mg/dl\[3.3mmol/l\], area under the curve (AUC greater/equal 180)and time (t greater/equal 180) for blood glucose greater/equal 180mg/dl\[10.0mmol/l\].
• Area under the curve (AUC smaller/equal 60)and time(t smaller/equal 60)for blood glucose smaller/equal 60mg/dl\[3.3mmol/l\]during the day (AUC 06.00am - 10.00pm)and during the night(AUC 10.00pm - 06.00am).
• Area under the curve (AUC greater/equal 180)and time(t greater/equal 180)for blood glucose greater/equal 180mg/dl\[10.0mmol/l\]during the day (AUC 06.00am - 10.00pm)and during the night(AUC 10.00pm - 06.00am).
• Frequency of subjects with nocturnal blood glucose value smaller/equal 60mg/dl\[3.3 mmol/l\].
• Frequency of subjects with asymptomatic nocturnal blood glucose smaller/equal 60mg/dl\[3.3 mmol/l\].
• Frequency of subjects with symptomatic nocturnal blood glucose smaller/equal 60mg/dl \[3.3 mmol/l\].
• Frequency of subjects with daytime blood glucose smaller/equal 60mg/dl \[3.3 mmol/l\].
• Frequency of subjects with asymptomatic daytime blood glucose smaller/equal 60mg/dl\[3.3 mmol/l\].
• Frequency of subjects with symptomatic daytime blood glucose smaller/equal 60mg/dl\[3.3 mmol/l\].
• Frequency of subjects with hyperglycemic blood glucose(greater/equal 180mg/dl,\[10.0mmol/l\]).
• Frequency of subjects with symptomatic hypoglycemia(smaller/equal 60mg/dl \[3.3mmol\]).
• Frequency of subjects with severe hypoglycemia(smaller/equal 36mg/dl \[2.0mmol/l\]).
• Blood glucose values of 8-point profiles.
• Mean daytime \& mean nocturnal blood glucose of 8-point-profiles.
• HbA1c.
• Fasting blood glucose (FBG).
• Dose of insulin.
• Adjustment of insulin.
• Body weight, body mass index.