Self Titration With Apidra to Reach Target Study (START)
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
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