NCT02451137

A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)

A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,304 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (\<8% if age \>=65 years or with defined comorbidities or otherwise \<7%) at 6 months without documented symptomatic (Blood Glucose \<=70 mg/deciliter \[mg/dL\]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes initiating basal insulin therapy in a real world setting. Secondary Objectives: Compare Toujeo to other commercially available basal insulins at 6 months after initiating insulin therapy in a real world setting in terms of: * Participant persistence with assigned basal insulin therapy. * Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia. * Changes in HbA1c, fasting plasma glucose, body weight * Differences in participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES). * Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.

Detailed description

The total study duration per patient will be up to 53 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, 300 U/ml	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Insulin glargine, 100 U/ml	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Insulin detemir	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Background Therapy	Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin.

Timeline

• Start date: 2015-06-16
• Primary completion: 2018-03-02
• Completion: 2018-08-09
• First posted: 2015-05-21
• Last updated: 2019-09-10
• Results posted: 2019-05-01

Locations

427 sites across 2 countries: United States, Canada