title: Glycaemic control and hypoglycaemia burden in patients with type 2 diabetes initiating basal insulin in Europe and the USA.
abstract: To evaluate short- and long-term glycaemic control and hypoglycaemia incidence in insulin-naïve patients ≥30 years of age with type 2 diabetes (T2DM) initiating basal insulin (BI) with or without oral anti-hyperglycaemic drugs (OADs).
  
  
  
  This was an observational, retrospective longitudinal analysis of electronic medical records from 5 European countries and the USA. A multivariable logistic regression model assessed baseline and short-term (0-3 months post BI initiation) factors associated with long-term (3-24 months) glycaemic control and hypoglycaemia.
  
  
  
  Overall, 40 627 patients were included; 20.9% and 27.8% achieved the general HbA1c target of ≤7% at 3 and 24 months post BI initiation, respectively. Failure to achieve HbA1c ≤7% at 3 months was associated with increased risk of failing to achieve target at 24 months (odds ratio [OR], 3.70 [95% CI, 3.41-4.00]). Over 24 months, 8.9% of patients experienced a recorded hypoglycaemic event. Hypoglycaemia during the initial 3-month period was associated with longer-term risk of these events over the ensuing 3 to 24 months (OR, 5.71 [95% CI, 4.67-6.99]).
  
  
  
  Initiating BI with or without OADs is associated with short- and long-term suboptimal glycaemic control; the majority of patients fail to achieve HbA1c target ≤7% in the first 3 months, or after 2 years of BI treatment. Treatment response and hypoglycaemia incidence by 3 months post BI initiation are associated with longer-term glycaemic control and hypoglycaemic risk, respectively. These results support the need for early anti-hyperglycaemic interventions that more effectively control blood glucose levels without increasing the risk of hypoglycaemia.
authors.affiliation: Department of Endocrinology & Nutrition, Hospital Universitari Germans Trias i Pujol, CIBERDEM, Badalona, Spain.
authors.forename: Dídac
authors.identifier: 0000-0002-2868-0250
authors.initials: D
authors.lastname: Mauricio
authors.affiliation: Division of Endocrinology, University of Texas Southwestern Medical Center, Dallas, Texas.|Parkland Health and Hospital System, Dallas, Texas.
authors.forename: Luigi
authors.initials: L
authors.lastname: Meneghini
authors.affiliation: Division of Endocrinology and Diabetology, Department of Medicine II, Faculty of Medicine, Medical Center - University of Freiburg, Freiburg, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Seufert
authors.affiliation: Sanofi, Bridgewater, New Jersey.
authors.forename: Laura
authors.initials: L
authors.lastname: Liao
authors.affiliation: Sanofi, Bridgewater, New Jersey.
authors.forename: Hongwei
authors.initials: H
authors.lastname: Wang
authors.affiliation: Sanofi, Bridgewater, New Jersey.
authors.forename: Liyue
authors.initials: L
authors.lastname: Tong
authors.affiliation: Sanofi, Paris, France.
authors.forename: Anna
authors.initials: A
authors.lastname: Cali
authors.affiliation: Sanofi, Paris, France.
authors.forename: Peter
authors.initials: P
authors.lastname: Stella
authors.affiliation: Sanofi, Paris, France.
authors.forename: Paulo
authors.initials: P
authors.lastname: Carita
authors.affiliation: Diabetes Research Centre, University of Leicester, Leicester, UK.
authors.forename: Kamlesh
authors.initials: K
authors.lastname: Khunti
mesh_terms: D015897:Comorbidity; D017281:Cost of Illness; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004351:Drug Resistance; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005060:Europe / Q000453:epidemiology; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000453:epidemiology / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007328:Insulin / Q000009:adverse effects / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D064887:Observational Studies as Topic; D015995:Prevalence; D012189:Retrospective Studies; D012306:Risk; D014481:United States / Q000453:epidemiology
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human
keywords: basal insulin; glycaemic control; hypoglycaemia; type 2 diabetes