Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement

10-week, Open, National, Multicenter Clinical Trial to Evaluate the Safety of Insulin Glargine in Type 2 Diabetes Mellitus Patients, on Intensified Conventional Therapy (ICT)

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.