Effects of insulin initiation on patient-reported outcomes in patients with type 2 diabetes: Results from the DURABLE trial

Diabetes Research and Clinical Practice

Volumn 89, Issue 2, 2010, Pages 157-166

  Lee, Lauren J ^a   Fahrbach, Jessie L ^b   Nelson, Lauren M ^c   McLeod, Lori D ^c   Martin, Sherry A ^b   Sun, Peter ^d   Weinstock, Ruth S ^e  

^a ELI LILLY AND COMPANY   (United States)

^b Lilly USA   (United States)

^c RTI HEALTH SOLUTIONS   (United States)

^d Kailo Research Group   (United States)

^e SYRACUSE VA MEDICAL CENTER   (United States)

Author keywords

Insulin initiation; Quality of life; Symptoms

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; INSULIN GLARGINE; INSULIN LISPRO; METFORMIN; SULFONYLUREA; ANTIDIABETIC AGENT; GLARGINE; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; INSULIN; LONG ACTING INSULIN;

ADULT; ANXIETY; ARTICLE; CARDIOVASCULAR EFFECT; CHECKLIST; COGNITION; CONTROLLED STUDY; DIABETES 39; DIABETES CONTROL; ENERGY; FATIGUE; FEMALE; HEALTH STATUS; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; NEUROPATHIC PAIN; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT ASSESSMENT; PATIENT MOBILITY; PSYCHOLOGICAL WELL BEING; QUALITY OF LIFE; QUESTIONNAIRE; RAND 36; RATING SCALE; SELF REPORT; SOCIAL STATUS; SYMPTOM; TREATMENT OUTCOME; VISION; AGED; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL;

ADULT; AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MALE; MIDDLE AGED; TREATMENT OUTCOME; INSULIN, LONG-ACTING;

EID: 77955094348     PISSN: 01688227     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.diabres.2010.04.002     Document Type: Article

References (47)

1. Nathan D.M., Buse J.B., Davidson M.B., Ferrannini E., Holman R.R., Sherwin R., et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diab. Care 2009, 32:193-203.
2. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998, 352:837-853. U.K. Prospective Diabetes Study Group (UKPDS).
3. Yki-Jarvinen H., Kauppila M., Kujansuu E., Lahti J., Marjanen T., Niskanen L., et al. Comparison of insulin regimens in patients with non-insulin-dependent diabetes mellitus. N. Engl. J. Med. 1992, 327:1426-1433.
4. Malone J.K., Kerr L.F., Campaigne B.N., Sachson R.A., Holcombe J.H. Combined therapy with insulin lispro mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin. Ther. 2004, 26:2034-2044. Lispro Mixture-Glargine Study Group.
5. Malone J.K., Bai S., Campaigne B.N., Reviriego J., Augendre-Ferrante B. Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with type 2 diabetes. Diab. Med. 2005, 22:374-381.
6. Raskin P., Allen E., Hollander P., Lewin A., Gabbay R.A., Hu P., et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diab. Care 2005, 28:260-265. INITIATE Study Group.
7. Rosenstock J., Schwartz S.L., Clark C.M., Park G.D., Donley D.W., Edwards M.B. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diab. Care 2001, 24:631-636.
8. Riddle M.C., Rosenstock J., Gerich J. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diab. Care 2003, 26:3080-3086. Insulin Glargine 4002 Study Investigators.
9. Janka H.U., Plewe G., Riddle M.C., Kliebe-Frisch C., Schweitzer M.A., Yki-Jarvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diab. Care 2005, 28:254-259.
10. Bradley C., Gilbride G.J.B. Improving treatment satisfaction and other patient-reported outcomes in people with type 2 diabetes: the role of once-daily insulin glargine. Diab. Obes. Metab. 2008, 10(Suppl. 2):50-65.
11. Polonsky W.H., Fisher L., Guzman S., Villa-Caballero L., Edelman S.V. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diab. Care 2005, 28:2543-2545.
12. Polonsky W.H. Emotional and quality-of-life aspects of diabetes management. Curr. Diab. Rep. 2002, 2:153-159.
13. Boye K.S., Matza L.S., Oglesby A., Malley K., Kim S., Hayes R.P., et al. Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes. Health Qual. Life Outcomes 2006, 4:80.
14. Grootenhuis P.A., Snoek F.J., Heine R.J., Bouter L.M. Development of a type 2 diabetes symptom checklist: a measure of symptom severity. Diab. Med. 1994, 11:253-261.
15. Hartman I. Insulin analogs: impact on treatment success, satisfaction, quality of life and adherence. Clin. Med. Res. 2008, 2:54-67.
16. Rubin R.R., Peyrot M. Psychological issues and treatments for people with diabetes. J. Clin. Psychol. 2001, 57:457-478.
17. Willke R.J., Burke L.B., Erickson P. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Control Clin. Trials 2004, 25:535-552.
18. Hendra T.J., Taylor C.D. A randomised trial of insulin on well-being and carer strain in elderly type 2 diabetic subjects. J. Diab. Complicat. 2004, 18:148-154.
19. Kotsanos J.G., Vignati L., Huster W., Andrejasich C., Boggs M.B., Jacobson A.M., et al. Health-related quality-of-life results from multinational clinical trials of insulin lispro: assessing benefits of a new diabetes therapy. Diab. Care 1997, 20:948-958.
20. de Grauw W.J., van de Lisdonk E.H., van Gerwen W.H., van den Hoogen H.J., van Weel C. Insulin therapy in poorly controlled type 2 diabetic patients: does it affect quality of life? Br. J. Gen. Pract. 2001, 51:527-532.
21. Witthaus E., Stewart J., Bradley C. Treatment satisfaction and psychological well-being with insulin glargine compared with NPH in patients with type 1 diabetes. Diab. Med. 2001, 18:619-625.
22. Ashwell S.G., Bradley C., Stephens J.W., Witthaus E., Home P.D. 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. Diab. Care 2008, 31:1112-1117.
23. Gray M., Boland E.A., Tamboriane W.V. Use of lispro insulin and quality of life in adolescents on intensive therapy. Diab. Educ. 1999, 25:934-941.
24. Houlden R., Ross S., Harris S., Yale J.F., Sauriol L., Gerstein H.C. Treatment satisfaction and quality of life using an early insulinization strategy with insulin glargine compared to an adjusted oral therapy in the management of type 2 diabetes: The Canadian INSIGHT Study. Diab. Res. Clin. Pract. 2007, 78:254-258.
25. Vinik A.I., Zhang Q. Adding insulin glargine versus rosiglitazone: health-related quality-of-life impact in type 2 diabetes. Diab. Care 2007, 30:795-800.
26. Reza M., Taylor C.D., Ward T.J.D., Ward J.D., Hendra T.J. Insulin improves well-being for selected elderly type 2 diabetic subjects. Diab. Res. Clin. Pract. 2002, 55:201-207.
27. Goddijn P.P., Bilo H.J., Feskens E.J., Groeniert K.H., van der Zee K.I., Meyboom-de Jong B. Longitudinal study on glycaemic control and quality of life in patients with type 2 diabetes mellitus referred for intensified control. Diab. Med. 1999, 16:23-30.
28. de Sonnaville J.J., Snoek F.J., Colly L.P., Devillé W., Wijkel D., Heine R.J. Well-being and symptoms in relation to insulin therapy in type 2 diabetes. Diab. Care 1998, 21:919-924.
29. Fischer J.S., McLaughlin T., Loza L., Beauchamp R., Schwartz S., Kipnes M. The impact of insulin glargine on clinical and humanistic outcomes in patients uncontrolled on other insulin and oral agents: an office-based naturalistic study. Curr. Med. Res. Opin. 2004, 20:1703-1710.
30. Fahrbach J., Jacober S., Jiang H., Martin S. The DURABLE trial study design: comparing the safety, efficacy, and durability of insulin glargine to insulin lispro mix 75/25 added to oral antihyperglycemic agents in patients with type 2 diabetes. J. Diab. Sci. Technol. 2008, 2:831-838.
31. Buse J.B., Wolffenbuttel B.H.R., Herman W.H., Shemonsky N.K., Jiang H., Fahrbach J.L., et al. DURAbility of Basal versus Lispro mix 25 insulin Efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diab. Care 2009, 32:1007-1013.
32. Ware J.J., Sherbourne C.D. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med. Care 1992, 30:473-483.
33. Hays R.D., Shapiro M.F. An overview of generic health-related quality of life measures for HIV research. Qual. Life Res. 1992, 1:91-97.
34. Stewart A.L., Sherbourne C.D., Hays R.D., Wells K.B., Nelson E.C., Kamberg C.J., et al. Summary and discussion of MOS measures. Measuring Functioning and Well-being: The Medical Outcomes Study Approach 1992, 345-371. Duke University Press, Durham, NC. A.L. Stewart, J.E. Ware (Eds.).
35. Boyer J.G., Earp J.L. The development of an instrument for assessing the quality of life of people with diabetes. Med. Care 1997, 35:440-453.
36. Van der Does F.E., De Neeling J.N., Snoek F.J., Kostense P.J., Grootenhuis P.A., Bouter L.M., et al. Symptoms and well-being in relation to glycemic control in type II diabetes. Diab. Care 1996, 19:204-210.
37. Cohen J. Statistical Power Analysis for the Behavioral Sciences 1988, Lawrence Erlbaum Associates, Hillsdale NJ. second ed.
38. American Diabetes Association Economic costs of diabetes in the U.S. in 2007. Diabetes Care 2008, 31:1-20.
39. Elgrably F., Costagliola D., Chwalow A.J., Varenne P., Slama G., Tchobroutsky G. Initiation of insulin treatment after 70 years of age: patient status 2 years later. Diab. Med. 1991, 8:773-777.
40. Peyrot M., Rubin R.R., Lauritzen T. The International DAWN Advisory Panel. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diab. Care 2005, 28:2673-2679.
41. Wallace T.M., Matthews D.R. Poor glycaemic control in type 2 diabetes: a conspiracy of disease, suboptimal therapy and attitude. Q. J. M. 2000, 93:369-374.
42. Dunning T. Exploring the world mythology of diabetes. Diab. Voice 2004, 49:30-33.
43. Meece J. Dispelling myths and removing barriers about insulin in type 2 diabetes. Diab. Educ. 2006, 32(Suppl. 1):9S-18S.
44. Snoek F., Skovlund S.E., Pouwer F. Development and validation of the Insulin Treatment Appraisal Scale (ITAS) in patients with type 2 diabetes. Health Qual. Life Outcomes 2007, 5:69.
45. Yki-Jarvinen, Juurinen L., Alvarsson M., Bystedt T., Galdwell I., Davies M., et al. Initiate Insulin by Aggressive Titration and Education (INITIATE): a randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups. Diab. Care 2007, 30:1364-1369.
46. Rubin R.R., Peyrot M. Quality of life and diabetes. Diab. Metab. Res. Rev. 1999, 15:205-218.
47. Rose M., Schirop T., Burkert U., Danzer G., Scholler G., Klapp B.F. Determinants of the quality of life of patients with diabetes under intensified insulin therapy. Diab. Care 1998, 21:1876-1885.