title: Impact of race/ethnicity on efficacy and safety of two starter insulin regimens in patients with type 2 diabetes: a posthoc analysis of the DURABLE trial.
abstract: OBJECTIVE
  To explore the impact of race/ethnicity on efficacy and safety of twice-daily insulin lispro mix 75/25 (LM75/25; 75% lispro protamine suspension, 25% insulin lispro) and once daily insulin glargine (GL).
  
  
  METHODS
  More than 2,000 Patients with type 2 diabetes enrolled in the 24-week initiation phase of the DURABLE Trial.
  
  
  METHODS
  Efficacy and safety variables at endpoint, including hemoglobin A1c (HbA1c), self-monitored plasma glucose (SMPG), and hypoglycemia, in each racial/ethnic group were compared to Caucasians within treatment groups.
  
  
  RESULTS
  Asian patients had less (LM75/25: -1.46%, P < .01; GL: -1.25%, P < .01) and Hispanic patients had greater (LM75/25: -2.17%) HbA1c reduction from baseline vs Caucasian patients (LM75/25: -1.84%; GL: -1.78%). Fewer Asian (LM75/25: 20%, P < .001; GL: 22%, P < .001) and Hispanic patients (LM75/25: 40%, P < .01) reached HbA1c target (< 7%) vs Caucasian patients (LM75/25: 53%; GL: 44%). Fasting plasma glucose was similar among groups, postprandial glucose (PPG) with GL was lower for African patients post-breakfast and post-dinner and higher for Asian patients post-lunch. Only PPG with LM75/25 was lower for Hispanic patients post-breakfast. Weight gain was lower in Asian patients (LM75/ 25). Insulin dose was higher for Asian (LM75/25 and GL) and lower for African patients (GL). Hypoglycemia rate was lower for Asian (LM75/25 and GL) and Hispanic patients (LM75/25).
  
  
  CONCLUSIONS
  There were significant efficacy and safety differences among racial/ethnic groups in the DURABLE trial. These differences may be important in designing insulin based treatment plans.
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, USA.
authors.forename: Jaime A
authors.initials: JA
authors.lastname: Davidson
authors.affiliation: University Medical Center, Groningen, University of Groningen, The Netherlands.
authors.forename: Bruce H
authors.initials: BH
authors.lastname: Wolffenbuttel
authors.affiliation: University of Hawaii at Manoa, Honolulu, USA.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Arakaki
authors.affiliation: Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: A Enrique
authors.initials: AE
authors.lastname: Caballero
authors.affiliation: Lilly USA, LLC, Indianapolis, Indiana 46285, USA.
authors.forename: Honghua H
authors.initials: HH
authors.lastname: Jiang
authors.affiliation: Lilly USA, LLC, Indianapolis, Indiana 46285, USA.
authors.forename: Dana S
authors.initials: DS
authors.lastname: Hardin
mesh_terms: D015190:Blood Glucose Self-Monitoring; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000208:ethnology*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin