Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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