A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin

• Status: Completed
• Trial end date: 2017-10-20

Summary

Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change

Secondary Objectives:

• To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change.

• To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.

• Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group).

• Change in fasting plasma glucose (FPG).

• Change in body weight.

• Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc).

• Change in hypoglycemic control subscale (HCS).

• Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Detemir; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human