Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement (SAFIR)

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.