A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2015
Primary Objective: To demonstrate noninferiority of Toujeo versus \"standard of care\" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change Secondary Objectives: * To demonstrate superiority of Toujeo versus \"standard of care\" basal insulin if noninferiority is met, measured as HbA1c change. * To compare Toujeo to other \"standard of care\" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification. * Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events \[as defined by the American Diabetes Association (ADA\] Workgroup on Hypoglycemia). * Change in fasting plasma glucose (FPG). * Change in body weight. * Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc). * Change in hypoglycemic control subscale (HCS) * Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.
Epistemonikos ID: cd7c2e93278953f6d545e88632e8d3f07aaeada2
First added on: May 20, 2024