A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
Status:
Completed
Trial end date:
2018-08-09
Target enrollment:
Participant gender:
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.