title: Health-related quality-of-life results from multinational clinical trials of insulin lispro. Assessing benefits of a new diabetes therapy.
abstract: OBJECTIVE
  To compare health-related quality of life (HRQOL) in patients with diabetes receiving insulin lispro with patients receiving regular human insulin (Humulin R).
  
  
  METHODS
  We performed two randomized comparative studies over a 6-month period (3 months per treatment). Primary analyses used crossover baseline to 3-month changes in HRQOL scores. Ninety-three principal investigators in Canada, France, Germany, and the U.S. participated in these studies. One HRQOL crossover study included 468 patients with type I diabetes; the other HRQOL crossover study included 474 patients with type II diabetes. In both studies, patients were taking insulin at least 2 months before enrollment. Primary outcomes included two generic HRQOL domains, energy/fatigue and health distress, and two diabetes-specific domains, treatment satisfaction and treatment flexibility. Thirty secondary outcomes included both generic and diabetes-specific measures. Secondary outcome domains were controlled for multiplicity in the analyses.
  
  
  RESULTS
  Primary analyses showed that treatment satisfaction scores (P < 0.001) and treatment flexibility scores (P = 0.001) were higher for insulin lispro in type I diabetic patients. No other significant treatment differences were detected using the data from these 6-month crossover studies.
  
  
  CONCLUSIONS
  Treatment satisfaction and treatment flexibility were significantly improved in patients with type I diabetes using insulin lispro. Other HRQOL findings were comparable for insulin lispro and regular human insulin. Insulin lispro appears to have a measurable impact on lifestyle benefits in patients with type I diabetes, as demonstrated by increased treatment satisfaction and treatment flexibility.
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center 46285, USA.
authors.forename: J G
authors.initials: JG
authors.lastname: Kotsanos
authors.forename: L
authors.initials: L
authors.lastname: Vignati
authors.forename: W
authors.initials: W
authors.lastname: Huster
authors.forename: C
authors.initials: C
authors.lastname: Andrejasich
authors.forename: M B
authors.initials: MB
authors.lastname: Boggs
authors.forename: A M
authors.initials: AM
authors.lastname: Jacobson
authors.forename: D
authors.initials: D
authors.lastname: Marrero
authors.forename: S D
authors.initials: SD
authors.lastname: Mathias
authors.forename: D
authors.initials: D
authors.lastname: Patrick
authors.forename: S
authors.initials: S
authors.lastname: Zalani
authors.forename: J
authors.initials: J
authors.lastname: Anderson
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D003710:Demography; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D005260:Female; D006304:Health Status; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061268:Insulin Lispro; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro