Dataset from Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs

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.