NCT02967224

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

A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to "Standard of Care" Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-Month Extension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 705 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The total study duration will be up to 55 weeks, consisting of a 1-week screening period at the site, a 26-week treatment period, and a 26-week extension period.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	insulin glargine (U300)	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	insulin glargine (U100)	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	NPH insulin	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	insulin detemir	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	insulin degludec	Pharmaceutical form: solution Route of administration: subcutaneous

Timeline

• Start date: 2015-11-05
• Primary completion: 2017-10-16
• Completion: 2017-10-16
• First posted: 2016-11-18
• Last updated: 2022-04-25

Locations

128 sites across 7 countries: Brazil, France, Germany, Ireland, Romania, Spain, United Kingdom