Sanofi Announces Program Of Phase IV Clinical Trials To Study Toujeo

(RTTNews) - Sanofi (SNYNF, SNY) announced a program of Phase IV clinical trials to study Toujeo (insulin glargine [rDNA origin] injection, 300 units per mL) in 'real-world' conditions.

The Real Life Study program in people with type 2 diabetes comprises the ACHIEVE CONTROL, REACH CONTROL and REGAIN CONTROL studies and will compare the clinical effectiveness of Toujeo with other basal insulins in a standard care setting, along with additional measures relating to patient experience and health resource utilization.

The research program will involve more than 4,500 adults with type 2 diabetes from the U.S. and Europe. It will investigate control of blood sugar levels, incidence of hypoglycemia, persistence with treatment, patient-reported outcomes and health resource usage, with Toujeo and other basal insulins as used in the standard care setting.

The ACHIEVE CONTROL study will evaluate the effect of Toujeo on achieving individualized glycemic targets without hypoglycemia at any time of day in 3,270 uncontrolled insulin-naïve people in the U.S. with type 2 diabetes. REACH CONTROL will follow 800 insulin-naïve people with type 2 diabetes in Europe, comparing HbA1c change with Toujeo vs. other basal insulins, alongside incidence of hypoglycemia, change in body weight, and measures of persistence with treatment and need for treatment intensification.

The REGAIN CONTROL study will compare HbA1c reduction, incidence of hypoglycemia, change in body weight and persistence with treatment on Toujeo vs. other basal insulins in 600 people with type 2 diabetes in Europe, who are currently uncontrolled on basal insulin.

In addition to clinical measures, the studies will also collect patient feedback on treatment satisfaction and their experience of hypoglycemia, along with healthcare resource utilization.

The studies are expected to begin randomizing patients in the second-quarter 2015, with initial results expected in 2017. Results from an extended follow-up period are anticipated in 2018.