ACHIEVE Control is a large (N=3304) randomized, prospective, pragmatic real-life study comparing effectiveness and safety of insulin glargine 300 U/mL (Gla-300) vs other basal insulins used as standard of care (SoC-BI) in insulin-naive patients with T2D. Gla-300 demonstrated superiority (p=0.03) in the primary composite endpoint of reaching individualized HEDIS A1C targets (<8% if ≥65 years or with defined comorbidities, <7% otherwise) without documented symptomatic (≤70 mg/dL) and/or severe hypoglycemia at 6 months. This post-hoc analysis assessed these 2 individualized targets separately to determine if the overall benefit observed is maintained in patients age >65 years or with comorbidities.
Insulin-naive patients with T2D, age ≥18 years, A1C 8-11%, under continuous care for ≥1 year before index date were randomized to Gla-300 or SoC-BI. Outcomes assessed in this analysis included A1C target attainment without hypoglycemia, and insulin dose in 2 subgroups: (1) age >65 years or with comorbidities (A1C target <8%); (2) age ≤65 years without comorbidities (A1C target <7%).
Patients in the A1C <8% subgroup were older than the <7% subgroup, had lower baseline mean body weight and longer duration of diabetes. In total, 702/1517 patients attained A1C target <8% (Gla-300, 48.4% vs SOC-BIs, 44.1%; OR: 1.17; 95% CI: 0.96-1.44) and 276/1787 attained A1C target <7% (Gla-300, 16.1% vs SOC-BIs, 14.8%; OR: 1.12; 95% CI: 0.86-1.44) without severe and/or confirmed symptomatic hypoglycemia. In the <8% subgroup, proportions of patients without hypoglycemia were: Gla-300, 79.2% vs SOC-BIs, 73.6% (OR: 1.36; 95% CI: 1.07-1.72). In the <7% subgroup, corresponding proportions were 77.7% and 76.6% (OR: 1.07; 95% CI: 0.86-1.34). Mean increases in BI dose from baseline to 6 months were 15.7U (Gla-300, 15.3U; SOC-BI, 16.2U) in A1C <8% and 19.8U (Gla-300 and SOC-B, each 19.8U) in A1C <7%.
Concern of hypoglycemia limits A1C goal attainment. We observed a trend for greater HEDIS A1C target attainment without hypoglycemia for Gla-300 vs SOC-BIs in both <8% and <7% target subgroups. This benefit was more pronounced, in part due to the hypoglycemia component, in the <8% subgroup, which represents older patients or those with comorbidities, who are typically more vulnerable to hypoglycemia and its adverse consequences.
Conclusion : Gla-300 demonstrated superiority in the primary composite endpoint of reaching individualized HEDIS A1C targets without hypoglycemia at 6 months. This analysis demonstrated that the efficacy and safety benefits of Gla-300 were maintained in older patients and those with comorbidities.
Luigi Meneghini– Professor and Executive Director, UT Southwestern Medical Center and Parkland Health & Hospital System
Debbie Hinnen– Advanced Practice Nurse and Certified Diabetes Educator, University of Colorado Health
Jasvinder Gill– Senior Medical Director, Sanofi US, Inc.
Pierre Evenou– Scientific Manager, Sanofi US, Inc.
Lydie Melas-Melt– Biostatistician, IVIDATA
John Anderson– Physician, The Frist Clinic
Professor and Executive Director
UT Southwestern Medical Center and Parkland Health & Hospital System
Luigi Meneghini, M.D., M.B.A., is a Professor of Internal Medicine at the University of Texas Southwestern Medical Center, Division of Endocrinology, in Dallas, Texas, and Executive Director of the Parkland Health and Hospital System Global Diabetes Program. Dr. Meneghini’s primary interests lie in improving the lives of patients with diabetes through the application of cutting edge therapies and technologies, and the implementation of these treatment strategies through patient and professional education activities. He has been involved in the development of treatment algorithms for glycemic control of type 1 and type 2 diabetes. At UT Southwestern he is charged with implementing a registry based chronic care model and exploring opportunities for leveraging this infrastructure to optimize population-based health management and translational research.
Advanced Practice Nurse and Certified Diabetes Educator
University of Colorado Health
Advanced Practice Nurse providing clinical care and education for T1, T2 and gestational PWD.
Senior Medical Director
Sanofi US, Inc.
Jasvinder Gill has over 20 years pharmaceutical experience in R&D and Medical Affairs. Dr. Gill has expertise in clinical trials, scientific communications, strategic development of launch activities, and medical strategy development for new brands. Dr. Gill has therapeutic expertise in diabetes and oncology.
Sanofi US, Inc.
Pierre Evenou is the Scientific Manager for Toujeo and Diabetes New Products, at Sanofi US. He has experience in design and synthesis siRNA vectors (organic chemistry, supramolecular polymer chemistry), antisense therapy application (cells culture and transfection), and virology.
Lydie Melas-Melt is a biostatistician for IVIDATA and Sanofi US. Her primary focus at Sanofi is with Clinical Sciences and Operations - Global Medical Affairs - Toujeo.
The Frist Clinic
John Anderson practices internal medicine and diabetes at the Frist Clinic in Nashville Tennessee. He has served as a Past President of the 38 member multi-specialty clinic, Chair of the Department of Medicine for two separate terms, and has been a member and Chair of the Board of Trustees of Centennial. In addition to his primary care practice, Dr. Anderson continues to consult lecture both nationally and internationally, with a focus on improving the care of people with diabetes in the primary care setting.