Insulin degludec improves health-related quality of life (SF-36®) compared with insulin glargine in people with Type 2 diabetes starting on basal insulin: A meta-analysis of phase 3a trials

Diabetic Medicine

Volumn 30, Issue 2, 2013, Pages 226-232

  Freemantle, N ^a   Meneghini, L ^b   Christensen, T ^c   Wolden, M L ^c   Jendle, J ^d   Ratner, R ^e  

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

^b UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^c NOVO NORDISK A S   (Denmark)

^d ÖREBRO UNIVERSITY   (Sweden)

^e AMERICAN DIABETES ASSOCIATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN DEGLUDEC; INSULIN GLARGINE; ORAL ANTIDIABETIC AGENT;

ARTICLE; GENDER; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEALTH; HUMAN; HYPOGLYCEMIA; INSULIN TREATMENT; META ANALYSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; QUALITY OF LIFE; SHORT FORM 36; TREATMENT DURATION;

BLOOD GLUCOSE; CLINICAL TRIALS, PHASE III AS TOPIC; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN, LONG-ACTING; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; QUALITY OF LIFE; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84872699790     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/dme.12086     Document Type: Article

References (30)

1. Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev 1999; 15: 205-218.
2. Lloyd A, Sawyer W, Hopkinson P. Impact of long-term complications on quality of life in patients with type 2 diabetes not using insulin. Value Health 2001; 4: 392-400.
3. Mulnier HE, Seaman HE, Raleigh VS, Soedamah-Muthu SS, Colhoun HM, Lawrenson RA. Mortality in people with Type 2 diabetes in the UK. Diabet Med 2006; 23: 516-521.
4. UK Prospective Diabetes Study (UKPDS) Group. 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.
5. Peyrot M, Rubin RR, Lauritzen T, Skovlund SE, Snoek FJ, Matthews DR et al. International DAWN Advisory Panel. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care 2005; 28: 2673-2679.
6. Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care 2010; 33: 240-245.
7. Goldney RD, Phillips PJ, Fisher LJ, Wilson DH. Diabetes, depression, and quality of life. Diabetes Care 2004; 27: 1066-1077.
8. Scoggins JF, Patrick DL. The use of patient-reported outcomes instruments in registered clinical trials: evidence from ClinicalTrials.gov. Contemp Clin Trials 2009; 30: 289-292.
9. Patrick DL, Erickson P. Health Status and Health Policy: Quality of Life in Health Care Evaluation and Resource Allocation. New York: Oxford University Press, 1993.
10. 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, RI: QualityMetric Inc, 2007.
11. Jonassen I, Havelund S, Hoeg-Jensen T, Steensgaard DB, Wahlund PO, Ribel U. Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res 2012; 29: 2104-2114.
12. 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.
13. Heise T, Tack CJ, Cuddihy R, Davidson J, Gouet D, Liebl A 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.
14. Birkeland KI, Home PD, Wendisch U, Ratner RE, Johansen T, Endahl LA et al. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care 2011; 34: 661-665.
15. Zinman B, Fulcher G, Rao PV, Thomas N, Endahl LA, Johansen T et al. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet 2011; 377: 924-931.
16. Garber AJ, King AB, Del Prato S, Sreenan S, Balci MK, Muñoz-Torres M et al; NN1250-3582 (BEGIN BB T2D) Trial Investigators. Insulin degludec, an ultra-long-acting 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.
17. Home PD, Meneghini L, Wendisch U, Ratner RE, Johansen T, Christensen TE et al. Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes. Diabet Med 2012; 29: 716-720.
18. 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.
19. Heller S, Buse J, Fisher M, Garg S, Marre M, Merker L et al; BEGIN Basal-Bolus Type 1 Trial Investigators. Insulin degludec, an ultra-long-acting 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.
20. Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H 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 2012. doi: 10.1111/dom.12032.
21. Bergenstal R, Bhargava A, Jain R, Unger J, Rasmussen S, Mersebach H et al. 200 U/mL insulin degludec improves glycemic control similar to insulin glargine with a low risk of hypoglycemia in insulin-naïve people with type 2 diabetes. Presented at AACE 21st Annual Scientific and Clinical Congress, Philadelphia, PA, May 2012: A26. Available at http://am.aace.com/sites/all/files/abstract-2012.pdf Last accessed 23 July 2012.
22. 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. Diabetes 2012; 61: A272.
23. ™ Once Long) Trial Investigators. 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.
24. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992; 30: 473-483.
25. Akaike H. A new look at the statistical model identification. IEEE Trans Automat Contr 1974; 19: 716-723.
26. 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.
27. Fayers PM, Hays RD, eds. Assessing Quality of Life in Clinical Trials: Methods and Practice, 2nd edn. Oxford: Oxford University Press, 2005: 4-6.
28. Hartman I. Insulin analogs: impact on treatment success, satisfaction, quality of life, and adherence. Clin Med Res 2008; 6: 54-67.
29. Horvath K, Jeitler K, Berghold A, Ebrahim SH, Gratzer TW, Plank J et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev 2007; 18: CD005613.
30. Freemantle N, Drummond M. Should clinical trials with concurrent economic analyses be blinded? J Am Med Assoc 1997; 277: 63-64.