Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    


Intervention name(s): Insulin glargine
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment