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A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)

Sanofi · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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diabetes-mellitustype-2
Primary Objective: Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (\=65 years or with defined comorbidities or otherwise \<7%) at 6 months without documented symptomatic (Blood Glucose \<=70 mg/deciliter \[mg/dL\]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes initiating basal insulin therapy in a real world setting. Secondary Objectives: Compare Toujeo to other commercially available basal insulins at 6 months after initiating insulin therapy in a real world setting in terms of: * Participant persistence with assigned basal insulin therapy. * Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia. * Changes in HbA1c, fasting plasma glucose, body weight * Differences in participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES). * Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.
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