title: Factors associated with failure to achieve a glycated haemoglobin target of <8.0% in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
abstract: The aim of this study was to identify the clinical features of participants in the standard therapy arm of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) glycaemia trial who failed to reach the glycated haemoglobin (HbA1c) target. We analysed 4685 participants in the standard therapy arm, comparing participants who reached the HbA1c target of <8.0% with those whose HbA1c level was ≥8.0% 12 months after randomization. Baseline and 12-month clinical characteristics were compared. At 12 months after randomization, 3194 participants had HbA1c <8.0% and 1491 had HbA1c ≥8.0%. Black race [odds ratio (OR) 0.74, 95% confidence interval (CI) 0.61-0.89; p = 0.002], severe hypoglycaemia (OR 0.57, CI 0.37-0.89; p = 0.014) and insulin use (OR 0.51, CI 0.40-0.65; p < 0.001) were associated with failure to reach HbA1c goal at 12 months in the adjusted model. Even with free medications, free visits with clinicians and aggressive titration of medications, >30% of participants in the standard arm of the ACCORD trial had an HbA1c ≥8.0% at 1 year. Participants who were black, had severe hypoglycaemia and were on insulin were more likely to have an above-target HbA1c concentration after 12 months on the standard protocol.
authors.affiliation: Division of Endocrinology and Diabetes, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
authors.forename: T C
authors.initials: TC
authors.lastname: Drake
authors.affiliation: Division of Public Health Sciences, Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: F-C
authors.initials: FC
authors.lastname: Hsu
authors.affiliation: Division of Public Health Sciences, Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: D
authors.initials: D
authors.lastname: Hire
authors.affiliation: Division of Public Health Sciences, Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: S-H
authors.initials: SH
authors.lastname: Chen
authors.affiliation: Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Cincinnati and Medical Service, Cincinnati VA Medical Center, Cincinnati, OH, USA.
authors.forename: R M
authors.initials: RM
authors.lastname: Cohen
authors.affiliation: Clinical Translational Unit, Department of Medicine, Tulane University, New Orleans, LA, USA.
authors.forename: R
authors.initials: R
authors.lastname: McDuffie
authors.affiliation: Division of Endocrinology, Department of Medicine, VAMC, Washington, DC, USA.
authors.forename: E
authors.initials: E
authors.lastname: Nylen
authors.affiliation: Center for Chronic Care Innovation, HealthPartners Institute for Education and Research, Minneapolis, MN, USA.
authors.forename: P
authors.initials: P
authors.lastname: O'Connor
authors.affiliation: Department of Medicine, Phoenix VA Healthcare Systems, University of Arizona College of Medicine, Phoenix, AZ, USA.
authors.forename: S
authors.initials: S
authors.lastname: Rehman
authors.affiliation: Division of Endocrinology and Diabetes, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
authors.forename: E R
authors.initials: ER
authors.lastname: Seaquist
mesh_terms: D000368:Aged; D044383:Black People / Q000706:statistics & numerical data; D001786:Blood Glucose / Q000032:analysis; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000150:complications / Q000188:drug therapy / Q000208:ethnology; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D012307:Risk Factors; D017211:Treatment Failure
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human
keywords: antidiabetic drug; clinical trial; cost-effectiveness; diabetes complications; insulin therapy; type 2 diabetes