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

Study 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.

Primary Outcome

HEDIS criteria: Individualized HbA1c target \<8% if age \>= 65 years or presence of medical comorbidities, or otherwise \<7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of \<=70 milligrams per deciliter (mg

Conditions Studied

Interventions

• DRUG Insulin detemir
• DRUG Insulin glargine, 300 U/ml
• DRUG Insulin glargine, 100 U/ml
• DRUG Background Therapy

Study Locations (20)