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

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.

Timeline

Start

2015-06-16

Primary completion

2018-03-02

Completion

2018-08-09

Publications

• Anderson J, Meneghini L, Hinnen D, Gill J, Coudert M, Evenou P, Munshi M. Target attainment in insulin-naive patients at high risk for hypoglycemia: Results from ACHIEVE Control. J Diabetes Complications. 2021 Apr;35(4):107831. doi: 10.1016/j.jdiacomp.2020.107831. Epub 2020 Dec 31.
• Oster G, Sullivan SD, Dalal MR, Kazemi MR, Rojeski M, Wysham CH, Sung J, Johnstone B, Cali AM, Wei LJ, Traylor L, Anhalt H, Hull M, Van Vleet J, Meneghini LF. Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naive patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):731-739. doi: 10.1080/00325481.2016.1241663. Epub 2016 Oct 24.

Drugs

Indications