Objective : ACHIEVE Control, a large (N=3290), prospective, randomized, pragmatic real-life study, demonstrated the superiority of insulin glargine 300 U/mL (Gla-300) vs other basal insulins used in the standard-of-care setting (SOC-BIs: insulin detemir and insulin glargine 100 U/mL) in attaining individualized Healthcare Effectiveness Data and Information Set (HEDIS) A1C targets at 6 months without hypoglycemia in insulin-naive patients with type 2 diabetes (T2D) (31.3% vs 27.9%; odds ratio [OR]: 1.19; 95% confidence interval [CI]: 1.01-1.39; p=0.03 for superiority). This analysis examined the effects of concomitant sulfonylurea (SU) use on hypoglycemia outcomes and individualized HEDIS A1C target attainment.
Methods : Patients were divided into two subgroups: patients who received concomitant SU at randomization, and those who did not receive SU. Hypoglycemia outcomes were captured as incidence and event rates of documented symptomatic hypoglycemia (≤70 mg/dL) and/or severe hypoglycemia at any time during 6 months of follow-up.
Results : Overall, concomitant SU use in this study was 69.4%, with 1148 and 1137 SU users and 496 and 509 non-SU users in the Gla-300 and SOC-BIs arms, respectively. Among SU users, attainment of the primary endpoint of HEDIS A1C target attainment without hypoglycemia was 29.8% and 25.2% in the Gla-300 and SOC-BIs arm, respectively (OR: 1.27; 95% CI: 1.05–1.54). In the non-SU group, attainment of the primary endpoint was 34.9% and 34.0% (OR: 1.04; 95% CI: 0.79-1.36) for Gla-300 and SOC-BIs, respectively. Hypoglycemia rates among SU vs non-SU users, regardless of HEDIS A1C target, was 24.0% vs 16.3% for Gla-300 and 27.4% vs 18.7% for SOC BIs. Among SU users, 76.0% and 72.6% of patients using Gla-300 vs SOC-BIs, respectively, completed the study without severe and/or documented symptomatic hypoglycemia (OR: 1.19; 95% CI: 0.99-1.44); among non-SU users, the proportions of patients were 83.7% and 81.3% for Gla-300 and SOC-BIs, respectively (OR: 1.18; 95% CI: 0.85-1.63).
Discussion : The results of this analysis are consistent with those of the overall population of ACHIEVE Control. Concomitant SU use with BIs, which is high in the real-world setting, can contribute to increased risk of hypoglycemia and attenuate A1C goal attainment without hypoglycemia. However, despite SU use, attainment of HEDIS A1C targets without hypoglycemia was greater with Gla-300 than with SOC-BIs.
Conclusion : This sub-analysis of ACHIEVE Control, a pragmatic real-life study of insulin-naive patients with T2D, demonstrated that despite concomitant SU use the benefit of Gla-300 over SOC-BIs in attaining HEDIS A1C targets without hypoglycemia was maintained.
Timothy Bailey– Clinical Assistant Professor, UCSD School of Medicine, 2AMCR Institute Inc., Escondido, California
Jasvinder Gill– Senior Medical Director, Sanofi US, Inc.
Pierre Evenou– Scientific Manager, Sanofi US, Inc.
Paulos Berhanu– Senior Medical Director, Sanofi US, Inc., Bridgewater, New Jersey
Lydie Melas-Melt– Biostatistician, IVIDATA
Jodi Strong– Diabetologist, Ascension Health, Stevens Point, Wisconsin
Eugene Wright– Consulting Associate, Duke Southern Regional AHEC, Fayetteville, North Carolina
Clinical Assistant Professor, UCSD School of Medicine
2AMCR Institute Inc.
Board certified in endocrinology, metabolism and internal medicine, Dr. Bailey has specialized in treating AMCR patients with diabetes, osteoporosis, thyroid diseases and lipid disorders since 1990. A clinical associate professor at the University of California San Diego School of Medicine, he is very active in conducting clinical trials, educating patients and physicians, and consulting with technology firms to improve patient care.
Education 1984 Mount Sinai School of Medicine
Post Doctoral Training 1984-1987 Internal Medicine Residency (St. Luke's Hospital, New York)
Research Fellowships 1987-1990 Endocrinology & Metabolism (SUNY Downstate Health Science Center)
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.
Senior Medical Director
Sanofi US, Inc.
Bridgewater, New Jersey
Senior Medical Director, Diabetes Medical Unit, Sanofi US Inc.
Executive Medical Director at Takeda Pharmaceuticals. Led and coordinated Medical Affairs activities in supporting diabetes, obesity and cardio-metabolic therapeutic areas.
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.
Stevens Point, Wisconsin
Diabetologist - Diabetes Services, Ascension Medical Group
Duke Southern Regional AHEC
Fayetteville, North Carolina
Dr. Eugene E. Wright, Jr. holds appointments as Consulting Associate in the Department of Community and Family Medicine and the Department of Medicine of Duke University Medical Center and as Clinical Associate Professor at the Campbell University School of Osteopathic Medicine (CUSOM). He teaches and precepts medical students and Family Medicine residents and has been involved with the Diabetes and Obesity Fellowship Training program at the Southern Regional AHEC in Fayetteville, NC.