Primary objectives : * To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. * To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. Secondary objectives : * To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c \<= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
811
One daily injection in the evening. 100 U/ml
Given immediately before each of the three main meals. 100 U/ml
At same dosages as the previous treatment
sulfonylurea or glinide
Sanofi-Aventis
Brussels, Belgium
Sanofi-Aventis
Paris, France
Sanofi-Aventis
Berlin, Germany
Sanofi-Aventis
Athens, Greece
Sanofi-Aventis
Budapest, Hungary
Sanofi-Aventis
Dublin, Ireland
Sanofi-Aventis
Milan, Italy
Sanofi-Aventis
Vilnius, Lithuania
Sanofi-Aventis
México, Mexico
Sanofi-Aventis
Gouda, Netherlands
...and 8 more locations
HbA1c
Time frame: From the beginning to the end of the study
24-hour blood glucose levels
Time frame: From the beginning to the end of the study
symptomatic hypoglycemia (diurnal and nocturnal)
Time frame: From the beginning to the end of the study
Severe hypoglycemia (diurnal and nocturnal),
Time frame: From the beginning to the end of the study
Insulin doses
Time frame: From the beginning to the end of the study
Vital signs
Time frame: From the beginning to the end of the study
Adverse events
Time frame: From the beginning to the end of the study
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