Diabetes Mellitus, Type 2
Conditions
Brief summary
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
Interventions
DRUGinsulin glargine
pre-filled disposable pen, in package of 5.
DRUGApidra (insulin glulisine)
pre-filled disposable pen, in package of 5
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Run-in phase: * T2DM * Treated for at least 3 months with a basal insulin (insulin glargine, NPH, detemir) +/- oral antidiabetic drugs (OADs) with an HbA1c \>7.0% or insulin naive (2-3 OADs) with an HbA1c \>=7.8% (historic HbA1c result up to 3 months of screening is acceptable) Randomized treatment phase: * Completed run-in phase * HbA1c \>7.0% and \>= 1 episode of confirmed nocturnal hypoglycemia (BG \<4.0 mmol/L) or \>= 2 measurements of FG \<=6.0 mmol/L within the previous week Patients who completed the run-in phase with HbA1c \>7.0% and did not meet the randomization criteria will continue titrating insulin glargine and be followed until the end of study.
Exclusion criteria
* No food intake before lunch (noon) * Unstable diet intake or significant changes to current diet regimen * Nightshift worker * Type 1 Diabetes Mellitus * Subjects unwilling to inject insulin or perform self-monitoring blood glucose * Pregnant, alcohol or drug abuse * Active cancer or any other disease or condition which in the opinion of the investigator would make the subject unsuitable for participation in the study * Any clinical significant laboratory findings that in the judgment of the investigator would preclude safe completion of the study * Known allergies to study drugs The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia | at week 36 (end of study) |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c, FG, and 7-point glucose profile | from Week 12 (randomization) to Week 24 and Week 36 |
| Change in weight | from Week 12 to Week 24 and to Week 36 |
| Incidence of hypoglycemia | Week 12 , Week 24 and Week 36 |
| Treatment satisfaction (DTSQ for patient ) | from Week 12 to Week 36 |
| Adherence with the patient-managed monitoring algorithm | Week 12 , Week 24 and Week 36 |
Countries
Canada
Outcome results
None listed