Type 2 Diabetes Mellitus Clinical Trial
Official title:
A 12 Week, Parallel, Open-label, Randomized, Multi-center Study Evaluating Use, Safety and Effectiveness of a Web Based Tool vs. Enhanced Usual Therapy of Glargine Titration in T2DM Patients With a 4 Week Safety Extension
Evaluating patients with type 2 diabetes either starting once daily basal insulin or requiring increased basal titrations in order to compare the LTHome web based tool with the usual standard of practice for insulin glargine dosing adjustment.
INNOVATE is a 12 week, parallel, open-label, randomized, multi-center study evaluating use,
safety and effectiveness of a web based tool (LTHome) vs. enhanced usual therapy (EUT) of
glargine titration in T2DM patients.
The primary objective of this study is to compare the effectiveness LTHome versus EUT of
glargine titration in people with T2DM patients on basal insulin not meeting local targets or
patients requiring basal initiation. Success will be measured by the percentage of subjects
reaching Canadian Diabetes Association (CDA) guideline targets.
The efficacy objective is to demonstrate that the percentage (%) of subjects to reach FPG
target by titration of insulin glargine using the LTHome tool with dose adjustment advice is
not inferior to the % of subjects to reach FPG target using Enhanced Usual Therapy glargine
titration during study participation (LTHome vs. EUT treatments).
The secondary objectives of this study are to assess safety, effectiveness, satisfaction and
adherence of LTHome use versus Enhanced Usual Therapy glargine titration.
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