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 (REGAIN CONTROL)

NCT02967211 PHASE4 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	PHASE4
Status	COMPLETED
Enrolment	609
Start date	Mon Dec 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Oct 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Diabetes Mellitus, Type 2

Interventions

• insulin glargine (U300)
• insulin glargine (U100)
• NPH insulin
• insulin detemir
• insulin degludec

Countries

France, Italy, Finland, Greece, Ireland, United Kingdom, Romania, Switzerland, Spain, Brazil