A comparison of health-related quality of life (health utility) between insulin degludec and insulin glargine: A meta-analysis of phase 3 trials

Diabetes, Obesity and Metabolism

Volumn 15, Issue 6, 2013, Pages 564-571

  Freemantle, N ^a   Evans, M ^b   Christensen, T ^c   Wolden, M L ^c   Bjorner, J B ^d,e  

^a ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

^b LLANDOUGH HOSPITAL   (United Kingdom)

^c NOVO NORDISK A S   (Denmark)

^d OPTUM   (United States)

^e UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Degludec; Diabetes; Glargine; Health utility; Insulin; Quality of life; SF 36

Indexed keywords

INSULIN DEGLUDEC; INSULIN GLARGINE;

ARTICLE; DIABETES MELLITUS; HEALTH STATUS; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; META ANALYSIS; MULTICENTER STUDY (TOPIC); NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL (TOPIC); QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SENSITIVITY ANALYSIS; SHORT FORM 36;

EID: 84877600809     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12086     Document Type: Article

References (43)

1. Coffey JT, Brandle M, Zhou H et al. Valuing health-related quality of life in diabetes. Diabetes Care 2002; 25: 2238-2243.
2. Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care 2005; 28: 2543-2545.
3. Currie CJ, Morgan CL, Poole CD, Sharplin P, Lammert M, McEwan P. Multivariate models of health-related utility and the fear of hypoglycaemia in people with diabetes. Curr Med Res Opin 2006; 22: 1523-1534.
4. Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care 2010; 33: 240-245.
5. Davis RE, Morrissey M, Peters JR, Wittrup-Jensen K, Kennedy-Martin T, Currie CJ. Impact of hypoglycaemia on quality of life and productivity in type 1 and type 2 diabetes. Curr Med Res Opin 2005; 21: 1477-1483.
6. Lundkvist J, Berne C, Bolinder B, Jönsson L. The economic and quality of life impact of hypoglycemia. Eur J Health Econ 2005; 6: 197-202.
7. Brod M, Christensen T, Thomsen TL, Bushnell DM. The impact of non-severe hypoglycemic events on work productivity and diabetes management. Value Health 2011; 14: 665-671.
8. Fidler C, Elmelund Christensen T, Gillard S. Hypoglycemia: an overview of fear of hypoglycemia, quality-of-life, and impact on costs. J Med Econ 2011; 14: 646-655.
9. Doward LC, Gnanasakthy A, Baker MG. Patient reported outcomes: looking beyond the label claim. Health Qual Life Outcomes 2010; 8: 89.
10. Wexler DJ, Grant RW, Wittenberg E et al. Correlates of health-related quality of life in type 2 diabetes. Diabetologia 2006; 49: 1489-1497.
11. Solli O, Stavem K, Kristiansen IS. Health-related quality of life in diabetes: The associations of complications with EQ-5D scores. Health Qual Life Outcomes 2010; 8: 18.
12. Weinstein MC, Torrance G, McGuire A. QALYs: The Basics. Value Health 2009; 12: S5-S9.
13. Jonassen I, Havelund S, Ribel U et al. Insulin degludec is a new generation ultra-long acting basal insulin with a unique mechanism of protraction based on multi-hexamer formation (Abstract). Diabetes 2010; 59: A11.
14. Heise T, Hermanski L, Nosek L, Feldmann A, Rasmussen S, Haahr H. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady state conditions in type 1 diabetes. Diabetes Obes Metab 2012; 14: 859-864.
15. Heise T, Tack CJ, Cuddihy R et al. A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Diabetes Care 2011; 34: 669-674.
16. Home PD, Fritsche A, Schinzel S, Massi-Benedetti M. Meta-analysis of individual patient data to assess the risk of hypoglycaemia in people with type 2 diabetes using NPH insulin or insulin glargine. Diabetes Obes Metab 2010; 12: 772-779.
17. Garber AJ, King AB, Del Prato S et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012; 379: 1498-1507.
18. Heller S, Buse J, Fisher M et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012; 379: 1489-1497.
19. Zinman B, Philis-Tsimikas A, Cariou B et al. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care 2012; 35: 2464-2471.
20. Ratner R, Gough SC, Mathieu C et al. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab 2013; 15: 175-184.
21. ®) compared with insulin glargine in people with Type 2 diabetes starting on basal insulin: a meta-analysis of phase 3a trials. Diabet Med 2012; 30: 226-232.
22. Home PD, Meneghini L, Wendisch U et al. Improved health status with insulin degludec compared with insulin glargine in people with type 1 diabetes. Diabet Med 2012; 29: 716-720.
23. Onishi Y, Park SW, Yoo SJ, Clauson P, Tamer SC, Iwamoto Y. Insulin degludec improves glycemic control in insulin-naïve patients with type 2 diabetes: results of a randomized pan-Asian trial (Abstract 1059-P). Diabetes 2012; 61(Suppl. 1): A272.
24. Meneghini L, Atkin SL, Gough SCL et al. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in people with type 2 diabetes. Diabetes Care 2013; DOI: 10.2337/dc12-1668 [Epub ahead of print].
25. Bergenstal R, Bhargava A, Jain RK, et al. 200 u/ml insulin degludec improves glycemic control similar to insulin glargine with a low risk of hypoglycemia in insulin-naive people with type 2 diabetes (Abstract). Presented at the AACE Scientific Meeting, Philadelphia, Pennsylvania, 23-27 May 2012. Available from URL: http://am.aace.com/2012/sites/all/files/abstract-061812.pdf. Accessed 29 September 2012.
26. ®: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. JCEM 2013; 98: 1154-1162.
27. Ware JE, Kosinski M, Bjorner JB, Turner-Bowker DM, Gandek B, Maruish ME. User's Manual for the SF-36v2 Health Survey. 2nd edn. Lincoln: QualityMetric Inc, 2007.
28. The EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208.
29. Rowen D, Brazier J, Roberts J. Mapping SF-36 onto the EQ-5D index: how reliable is the relationship? Health Qual Life Outcomes 2009; 7: 27.
30. Longworth L, Rowen D. NICE DSU Technical Support Document 10: The Use of Mapping Methods to Estimate Health State Utility Values. 2011. Available from URL: http://www.nicedsu.org.uk. Accessed 29 September 2012.
31. Brazier J, Roberts J, Deverill M. The estimation a preference-based single index measure for health from the SF-36. J Health Econ 2002; 21: 271-292.
32. Ara R, Brazier J. Deriving an algorithm to convert the eight mean SF-36 dimension scores into a mean EQ-5D preference-based score from published studies (where patient level data are not available). Value Health 2008; 11: 1131-1143.
33. Clarke P, Gray A, Holman R. Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62). Med Decis Making 2002; 22: 340-349.
34. Zhang P, Brown MB, Bilik D, Ackermann RT, Li R, Herman WH. Health utility scores for people with type 2 diabetes in U.S. managed care health plans: results from Translating Research Into Action for Diabetes (TRIAD). Diabetes Care 2012; 35: 2250-2256.
35. Akaike H. A new look at the statistical model identification. IEEE Trans Autom Control 1974; 19: 716-723.
36. Ashwell SG, Bradley C, Stephens JW, Witthaus E, Home PD. 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. Diabetes Care 2008; 31: 1112-1117.
37. Hartman I. Insulin Analogs: Impact on treatment success, satisfaction, quality of life, and adherence. Clin Med Res 2008; 6: 54-67.
38. Horvath K, Jeitler K, Berghold A et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev 2007; 18: CD005613.
39. Williams SA, Pollack MF, Dibonaventura M. Effects of hypoglycemia on health-related quality of life, treatment satisfaction and healthcare resource utilization in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract 2011; 91: 363-370.
40. Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA. Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. Diabetes Care 2000; 23: 639-643.
41. Drummond M. Introducing economic and quality of life measurements into clinical studies. Ann Med 2001; 33: 344-349.
42. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med 2011; 365: 2002-2012.
43. Brazier J, Roberts J, Tsuchiya A, Busschbach J. A comparison of the EQ-5D and SF-6D across seven patient groups. Health Econ 2004; 13: 873-884.