Self Titration With Apidra to Reach Target Study (START)

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

Timeline

Start

2009-10

Primary completion

2012-01

Completion

2012-01

Publications

• Harris SB, Yale JF, Berard L, Stewart J, Abbaszadeh B, Webster-Bogaert S, Gerstein HC. Does a patient-managed insulin intensification strategy with insulin glargine and insulin glulisine provide similar glycemic control as a physician-managed strategy? Results of the START (Self-Titration With Apidra to Reach Target) Study: a randomized noninferiority trial. Diabetes Care. 2014;37(3):604-10. doi: 10.2337/dc13-1636. Epub 2013 Oct 29.

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Indications