Health-related quality-of-life results from multinational clinical trials of insulin lispro: Assesing benefits of a new diabetes therapy

James G. Kotsanos, Louis Vignati, William Huster, Carol Andrejasich, Mary Beth Boggs, Alan M. Jacobson, David Marrero, Susan D. Mathias, Donald Patrick, Sunita Zalani, James Anderson

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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). RESEARCH DESIGN AND 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 l 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. RESULT - 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 1 diabetes, as demonstrated by increased treatment satisfaction and treatment flexibility.

Original languageEnglish
Pages (from-to)948-958
Number of pages11
JournalDiabetes Care
Volume20
Issue number6
StatePublished - Jun 1997

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Insulin Lispro
Quality of Life
Clinical Trials
Insulin, Regular, Human
Cross-Over Studies
Therapeutics
Type 1 Diabetes Mellitus
Insulin
Type 2 Diabetes Mellitus
France
Canada
Fatigue
Germany
Life Style
Research Design

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Kotsanos, J. G., Vignati, L., Huster, W., Andrejasich, C., Boggs, M. B., Jacobson, A. M., ... Anderson, J. (1997). Health-related quality-of-life results from multinational clinical trials of insulin lispro: Assesing benefits of a new diabetes therapy. Diabetes Care, 20(6), 948-958.

Health-related quality-of-life results from multinational clinical trials of insulin lispro : Assesing benefits of a new diabetes therapy. / Kotsanos, James G.; Vignati, Louis; Huster, William; Andrejasich, Carol; Boggs, Mary Beth; Jacobson, Alan M.; Marrero, David; Mathias, Susan D.; Patrick, Donald; Zalani, Sunita; Anderson, James.

In: Diabetes Care, Vol. 20, No. 6, 06.1997, p. 948-958.

Research output: Contribution to journalArticle

Kotsanos, JG, Vignati, L, Huster, W, Andrejasich, C, Boggs, MB, Jacobson, AM, Marrero, D, Mathias, SD, Patrick, D, Zalani, S & Anderson, J 1997, 'Health-related quality-of-life results from multinational clinical trials of insulin lispro: Assesing benefits of a new diabetes therapy', Diabetes Care, vol. 20, no. 6, pp. 948-958.
Kotsanos JG, Vignati L, Huster W, Andrejasich C, Boggs MB, Jacobson AM et al. Health-related quality-of-life results from multinational clinical trials of insulin lispro: Assesing benefits of a new diabetes therapy. Diabetes Care. 1997 Jun;20(6):948-958.
Kotsanos, James G. ; Vignati, Louis ; Huster, William ; Andrejasich, Carol ; Boggs, Mary Beth ; Jacobson, Alan M. ; Marrero, David ; Mathias, Susan D. ; Patrick, Donald ; Zalani, Sunita ; Anderson, James. / Health-related quality-of-life results from multinational clinical trials of insulin lispro : Assesing benefits of a new diabetes therapy. In: Diabetes Care. 1997 ; Vol. 20, No. 6. pp. 948-958.
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