Treatment Satisfaction and Quality of Life With Insulin Glargine Plus Insulin Lispro Compared With NPH Insulin Plus Unmodified Human Insulin in Individuals With Type 1 Diabetes
- Simon G. Ashwell, MD1,
- Clare Bradley, PHD2,
- James W. Stephens, MS3,
- Elke Witthaus, MD4 and
- Philip D. Home, DM, DPHIL1
- 1Newcastle University, Newcastle upon Tyne, U.K
- 2Royal Holloway, University of London, London, U.K
- 3sanofi-aventis, Bridgewater, New Jersey
- 4Health Outcomes Research, Accovion, Frankfurt, Germany
- Corresponding author: Dr. Simon G. Ashwell, Diabetes Care Centre, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW, U.K. E-mail: simon.ashwell{at}stees.nhs.uk
Abstract
OBJECTIVE—The purpose of this study was to compare quality of life (QoL) and treatment satisfaction using insulin glargine plus insulin lispro with that using NPH insulin plus unmodified human insulin in adults with type 1 diabetes managed with multiple injection regimens.
RESEARCH DESIGN AND METHODS—As part of a 32-week, five-center, two-way crossover study in 56 individuals with type 1 diabetes randomized to evening insulin glargine plus mealtime insulin lispro or to NPH insulin (once or twice daily) plus mealtime unmodified human insulin, the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the Audit of Diabetes Dependent Quality of Life questionnaire were completed at baseline and at weeks 16 and 32, with additional interim DTSQ measurements.
RESULTS—For all patients combined, the mean baseline present QoL score was 1.3, reflecting “good” QoL. Present QoL improved with glargine + lispro but did not change with NPH + human insulin (1.6 ± 0.1 [mean ± SEM] vs. 1.3 ± 0.1, difference 0.3 [95% CI 0.1–0.6]; P = 0.014). Baseline mean average weighted impact score (AWI) of diabetes on QoL was −1.8, indicating a negative impact of diabetes on QoL. The AWI score at end point improved significantly with glargine + lispro but changed little with NPH + human insulin (−1.4 ± 0.1 vs. −1.7 ± 0.1, 0.3 [0.0–0.6]; P = 0.033). Treatment satisfaction (DTSQ 36-0 scale score) at end point was markedly greater with glargine plus lispro compared with that for NPH plus human insulin (32.2 ± 3.4 vs. 23.9 ± 7.2, 8.6 [6.5–10.6]; P < 0.001).
CONCLUSIONS—Insulin glargine plus insulin lispro improves treatment satisfaction, reduces the negative impact of diabetes on QoL, and improves QoL in comparison with NPH insulin plus unmodified human insulin in type 1 diabetes.
- ADDQoL, Audit of Diabetes Dependent Quality of Life
- AWI, average weighted impact
- DAFNE, Dose Adjustment For Normal Eating
- DTSQ, Diabetes Treatment Satisfaction Questionnaire
- DTSQc, DTSQ change version
- DTSQs, DTSQ status version
- ITT, intention-to-treat
- QoL, quality of life
Footnotes
-
Published ahead of print at http://care.diabetesjournals.org on 13 March 2008. DOI: 10.2337/dc07-1183. Clinical trial reg. no. ISRCTN83582782, clinicaltrials.gov.
A list of participating investigators in this study can be found in the appendix.
S.G.A. has received speaker fees from sanofi-aventis. Newcastle University and Royal Holloway, University of London have received financial support from sanofi-aventis for the research/consultation/lecturing activities of S.G.A., C.B., and P.D.H. C.B. is a director and majority shareholder of Health Psychology Research Ltd. E.W. was employed by Hoechst (now part of sanofi-aventis) at the time the study was performed.
Additional information for this article can be found in an online appendix at http://dx.doi.org/10.2337/dc07-1183.
Copyright for the DTSQs, DTSQc, and ADDQoL is owned by Clare Bradley, from whom they may be obtained (c.bradley{at}rhul.ac.uk).
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.
-
- Accepted February 28, 2008.
- Received June 21, 2007.
- DIABETES CARE
