Primary Objective: The primary objective of this study is to demonstrate non-inferiority of a patient-managed titration algorithm (including blood glucose monitoring) for the addition of a single dose of insulin glulisine at breakfast in Canadian patients with inadequately controlled T2DM after optimization of basal insulin, compared with an HCP-managed titration algorithm. The primary endpoint for assessment of this objective is the percent of patients reaching a target HbA1c \<=7.0% without severe hypoglycemia at the end of the study. Secondary Objective: Secondary objectives of the study are to compare the effect of the two different insulin glulisine titration algorithms (patient-managed versus HCP-managed) on the following: * change in HbA1c, FG, and 7-point glucose profile at Week 24 and Week 36 * satisfaction with treatment (DTSQc for patient and questionnaire for HCP) at Week 36 * change in weight at Week 24 and Week 36 * incidence of hypoglycemia * insulin doses * resource utilization (rural/urban, blood glucose meter test strips, lancets, HCP visits, telephone calls, and hospitalizations) * adherence with the patient-managed monitoring algorithm
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
493
pre-filled disposable pen, in package of 5.
pre-filled disposable pen, in package of 5
Sanofi-Aventis Administrative Office
Laval, Canada
Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia
Time frame: at week 36 (end of study)
Change in HbA1c, FG, and 7-point glucose profile
Time frame: from Week 12 (randomization) to Week 24 and Week 36
Change in weight
Time frame: from Week 12 to Week 24 and to Week 36
Incidence of hypoglycemia
Time frame: Week 12 , Week 24 and Week 36
Treatment satisfaction (DTSQ for patient )
Time frame: from Week 12 to Week 36
Adherence with the patient-managed monitoring algorithm
Time frame: Week 12 , Week 24 and Week 36
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