title: Effect of gender on treatment outcomes in type 2 diabetes mellitus.
abstract: OBJECTIVE
  To evaluate the effect of gender on clinical outcomes in people with type 2 diabetes mellitus (T2DM) receiving antidiabetes therapy.
  
  
  METHODS
  This is a pooled analysis from nine similarly designed phase 3 and 4 randomized, controlled studies evaluating insulin glargine and an active comparator (NPH insulin, insulin lispro, premixed insulin, oral antidiabetes drugs, dietary intervention) in adults with T2DM. Impact of gender on outcomes including HbA1c, fasting plasma glucose (FPG), weight-adjusted insulin dose, and hypoglycemia incidence was evaluated after 24 weeks of treatment.
  
  
  RESULTS
  Overall, 1651 male and 1287 female individuals were included; 49.8% and 50.2% were treated with insulin glargine or comparators, respectively. Females receiving insulin glargine were less likely than males to achieve a glycemic target of HbA1c≤7.0% (53mmol/mol) (54.3% vs 60.8%, respectively, p=0.0162); there was no difference between females and males receiving comparators (52.7% vs 51.3%, respectively, p=0.4625). Females had significantly greater reductions in FPG (3.1mg/dL, p=0.0458), required significantly higher insulin doses (0.03IU/kg, p=0.0071), and had significantly higher annual rates of symptomatic (p<0.0001), glucose-confirmed (<50 and <70mg/dL) symptomatic (p=0.0005 and p<0.0001), and severe hypoglycemia (p=0.0020) than males.
  
  
  CONCLUSIONS
  Females in this analysis had smaller reductions in HbA1c and were less likely to reach glycemic goals despite higher insulin doses and more hypoglycemic events than males. Differences in gender responses to therapy should be considered when individualizing treatment for people with T2DM.
authors.affiliation: Washington University School of Medicine, St. Louis, MO, USA. Electronic address: jmcgill@dom.wustl.edu.
authors.forename: J B
authors.initials: JB
authors.lastname: McGill
authors.forename: A
authors.initials: A
authors.lastname: Vlajnic
authors.forename: P G
authors.initials: PG
authors.lastname: Knutsen
authors.forename: C
authors.initials: C
authors.lastname: Recklein
authors.forename: M
authors.initials: M
authors.lastname: Rimler
authors.forename: S J
authors.initials: SJ
authors.lastname: Fisher
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight / Q000187:drug effects; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Gender; Glycemic control; Hypoglycemia; Insulin glargine; Type 2 diabetes mellitus