Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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
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.
The total study duration per patient will be up to 53 weeks, consisting of a 1-week screening period at the site, a 26-week treatment period, and a 26-week extension period. ;
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