Health-related quality-of-life results from multinational clinical trials of insulin lispro. Assessing benefits of a new diabetes therapy.
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.
Kotsanos
J G
JG
Eli Lilly and Company, Lilly Corporate Center 46285, USA.
Vignati
L
L
Huster
W
W
Andrejasich
C
C
Boggs
M B
MB
Jacobson
A M
AM
Marrero
D
D
Mathias
S D
SD
Patrick
D
D
Zalani
S
S
Anderson
J
J
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
D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro