Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement
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.
Inclusion Criteria:

 -  Subjects with type 2 diabetes mellitus (no history of ketoacidosis)and stable
 treatment with NPH insulin(once or twice daily)and mealtime insulin for at least 3
 months.

 -  HbA1c values smaller/equal 8.0%(measured at screening visit, Visit 1).

 -  Ability and willingness to perform continuous and self monitoring blood glucose
 profiles, using a self monitoring blood glucose meter as well as carrying the
 continuous blood glucose meter at least two times for 72 hours throughout the study at
 home.

 Exclusion Criteria:

 -  All forms of diabetes other than type 2 diabetes mellitus.

 -  Oral antidiabetic drugs(OADs)and/or insulins other than NPH and mealtime insulins,
 except metformin(stable dose for a minimum of 3 months, no dose adjustments during the
 study).

 -  Pregnant(as determined by urine pregnancy test at Visit 1)or breast-feeding.

 -  Women of childbearing potential who did not take adequate contraceptive protection
 such as systemic hormones or who planned to become pregnant during the study.

 -  Likelihood of requiring treatment during the study period with drugs not permitted by
 the study protocol (e.g. systemic corticosteroids).

 -  History of hypersensitivity to the study medication or to drugs with similar chemical
 structures.

 -  Treatment with any investigational drugs in the last month before study entry.

 -  History of drug or alcohol abuse.

 -  Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in
 the 3 months prior to study entry or which required surgical treatment within the
 study.

 -  Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological,
 endocrine, hematological or other major systemic diseases making implementation of the
 protocol or interpretation of the study results difficult.

 -  Known impaired hepatic or renal function.

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.