A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus

Detailed Summary

Primary Objective: Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (\<8% if age \>=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.

Study Details

Timeline

Interventions