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

Summary

Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change Secondary Objectives: * To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as 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 the incidence of documented symptomatic or severe hypoglycemic events \[as defined by the American Diabetes Association (ADA\] Workgroup on Hypoglycemia). * 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.

Timeline

Start

2015-11-05

Primary completion

2017-10-16

Completion

2017-10-16

Publications

• Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
• Freemantle N, Mauricio D, Giaccari A, Bailey T, Roussel R, Franco D, Berthou B, Pilorget V, Westerbacka J, Bosnyak Z, Bonnemaire M, Cali AMG, Nguyen-Pascal ML, Penfornis A, Perez-Maraver M, Seufert J, Sullivan SD, Wilding J, Wysham C, Davies M. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus. Curr Med Res Opin. 2020 Apr;36(4):571-581. doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.

Drugs

Indications