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

Diabetes Care

Volumn 20, Issue 6, 1997, Pages 948-958

  Kotsanos, James G ^a   Vignati, Louis ^a   Huster, William ^a   Andrejasich, Carol ^a   Boggs, Mary Beth ^a   Jacobson, Alan M ^b   Marrero, David ^c   Mathias, Susan D ^d   Patrick, Donald ^e   Zalani, Sunita ^a   Anderson, James ^a  

^a ELI LILLY AND COMPANY   (United States)

^b JOSLIN DIABETES CENTER   (United States)

^c REGENSTRIEF INSTITUTE   (United States)

^d Technology Assessment Group   (United States)

^e UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMULIN ULTRALENTE; INSULIN LISPRO; INSULIN ZINC SUSPENSION; ISOPHANE INSULIN; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; FEMALE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SATISFACTION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

EID: 0030991976     PISSN: 01495992     EISSN: None     Source Type: Journal    
DOI: 10.2337/diacare.20.6.948     Document Type: Article

References (19)

1. Pocock SJ: A perspective on the role of quality-of-life assessment in clinical trial. Control Clin Trials 12 (Suppl. 4):257S-265S, 1991
2. Croog SH, Levine S, Testa MA, Brown B, Bulpitt CJ, Jenkins CD, Klerman GL, Williams GH: The effects of antihypertensive therapy on the quality of life. N Engl J Med 314:1657-1664, 1986
3. Schipper H, Clinch J, Powell V: Definitions and conceptual issues. In Quality of Life Assessments in Clinical Trials. Spilker B, Ed. New York, Raven, 1990, p. 11-24
4. Patrick DL, Erickson P: Health Status and Health Policy: Quality of Life in Health Care Evaluation and Resource Allocation. New York, Oxford Univ. Press, 1993, p. 20-23
5. Gill TM, Feinstein AR: A critical appraisal of the quality of quality-of-life measurements. JAMA 272:619-626, 1994
6. Wilson IB, Cleary PD: Linking clinical variables with health-related quality of life. JAMA 273:59-65, 1995
7. Waadt S, Duran G, Waadt M, Herschbach P, Strian F: Quality of life in patients with type II diabetes mellitus. In New Aspects in Diabetes. Lefèbvre PJ, Stabdl E, Eds. Berlin, Walter de Gruyter, 1992, p. 111-125
8. Bradley C, Gamsu DS: Guidelines for encouraging psychological well-being: report of a working group of the World Health Organization Regional Office for Europe and International Diabetes Federation European Region St. Vincent Declaration Action Programme for Diabetes. Diabet Med 11:510-516, 1994
9. Howey DC, Bowsher RR, Brunelle RL, Woodworth JR: [Lys(B28), Pro(B29)]-human insulin: a rapidly absorbed analogue of human insulin. Diabetes 43:396-402, 1994
10. Anderson JH, Brunelle RL, Koivisto VA, Trautmann ME, Vignati L, DiMarchi R, the Multicenter Insulin Lispro Study Group: Improved mealtime treatment of diabetes mellitus using insulin analogue. Clin Ther 19:62-72, 1997
11. Anderson JH, Brunelle RL, Koivisto VA, Pfutzner A, Trautmann ME, Vignati L, DiMarchi R, the Multicenter Insulin Lispro Study Group: Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analog treatment. Diabetes 46:265-270, 1997
12. Anderson JH, Brunelle RL, Keohane P, Koivisto VA, Trautmann M, Vignati L, DiMarchi R: Mealtime treatment with insulin analogue improves postprandial hyperglycemia and hypoglycemia in NIDDM patients. Arch Intern Med. In press
13. Pickup JC, Williams G (Eds.): Textbook of Diabetes. Vol. 1. Oxford, Blackwell Scientific Publications, 1991, chapter 6, p. 39
14. Kotsanos J, Huster W, Andrejasich C, Vignati L, Mathias S, Patrick D: Development and validation of a diabetes quality of life questionnaire for use in global clinical trials (Abstract). Diabetes 43 (Suppl. 1):155A, 1994
15. Mathias SD, Fifer SK, Patrick DL: Rapid translation of quality of life measures for international clinical trials: avoiding errors in the minimalist approach. Qual Life Res 3:403-412, 1994
16. Shen W, Brunelle R, Kotsanos JG: Validation of the diabetes quality of life clinical trial questionnaire using multinational data (Abstract). Qual Life Res 4:575, 1995
17. Koch GG: The use of non-parametric methods in the statistical analysis of the two-period change-over design. Biometrics 28:577-584, 1972
18. Hochberg Y: A sharper Bonferroni procedure for multiple tests of significance. Biometrika 75:800-802, 1988
19. Desmet M, Rutters A, Schmitt H, Satter E: [Lys(B28),Pro(B29)] human insulin (LysPro): patients treated with LysPro vs. human regular insulin: quality of life assessment (QOL) (Abstract). Diabetes 43 (Suppl. 1):167A, 1994