Clinical use of insulin degludec

Diabetes Research and Clinical Practice

Volumn 109, Issue 1, 2015, Pages 19-31

  Vora, Jiten ^a   Cariou, Bertrand ^b   Evans, Marc ^c   Gross, Jorge Luiz ^d   Harris, Stewart ^e   Landstedt Hallin, Lena ^f   Mithal, Ambrish ^g   Rodriguez, Martín Rodríguez ^h   Meneghini, Luigi ⁱ  

^a ROYAL LIVERPOOL UNIVERSITY HOSPITAL   (United Kingdom)

^b NANTES UNIVERSITY HOSPITAL   (France)

^c LLANDOUGH HOSPITAL   (United Kingdom)

^d Centro de Pesquisas em Diabetes   (Brazil)

^e WESTERN UNIVERSITY   (Canada)

^f DANDERYD HOSPITAL   (Sweden)

^g MEDANTA THE MEDICITY   (India)

^h UNIVERSIDAD NACIONAL DE CUYO   (Argentina)

ⁱ UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

Author keywords

Clinical practice; Diabetes; Dosing; Hypoglycaemia; Insulin; Insulin degludec

Indexed keywords

INSULIN ASPART PLUS INSULIN DEGLUDEC; INSULIN DEGLUDEC; INSULIN DEGLUDEC PLUS LIRAGLUTIDE; INSULIN GLARGINE; ORAL ANTIDIABETIC AGENT; SITAGLIPTIN; GLUCOSE BLOOD LEVEL; INSULIN; LONG ACTING INSULIN;

ANTIDIABETIC ACTIVITY; CLINICAL PRACTICE; CRYSTALLIZATION; DISEASE SEVERITY; DRUG ABSORPTION; DRUG DOSE TITRATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG STRUCTURE; EXERCISE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN RESISTANCE; INSULIN SENSITIVITY; META ANALYSIS (TOPIC); NAUSEA; NOCTURNAL HYPOGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; OXYGEN CONSUMPTION; PATIENT SATISFACTION; PHARMACODYNAMICS; QUALITY OF LIFE; RECOMMENDED DRUG DOSE; REVIEW; BLOOD; CHEMICALLY INDUCED; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION; DRUG EFFECTS; WEIGHT GAIN;

BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; HUMANS; HYPOGLYCEMIA; INSULIN; INSULIN GLARGINE; INSULIN, LONG-ACTING; WEIGHT GAIN;

EID: 84930818009     PISSN: 01688227     EISSN: 18728227     Source Type: Journal    
DOI: 10.1016/j.diabres.2015.04.002     Document Type: Review

References (73)

1. Holman R.R., Paul S.K., Bethel M.A., Matthews D.R., Neil H.A. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008, 359:1577-1589.
2. Nathan D.M., Cleary P.A., Backlund J-Y.C., Genuth S.M., Lachin J.M., Orchard T.J., et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005, 353:2643-2653. 10.1056/NEJMoa052187.
3. American Diabetes Association A.D. Standards of medical care in diabetes-2014. Diabetes Care 2014, 37:S14-S80. 10.2337/dc14-S014.
4. Inzucchi S.E., Bergenstal R.M., Buse J.B., Diamant M., Ferrannini E., Nauck M., et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012, 35:1364-1379. 10.2337/dc12-0413.
5. Brown J.B., Nichols G.A., Perry A. The burden of treatment failure in type 2 diabetes. Diabetes Care 2004, 27:1535-1540.
6. Khunti K., Vora J., Davies M. Results from the UK cohort of SOLVE: providing insights into the timing of insulin initiation in people with poorly controlled type 2 diabetes in routine clinical practice. Prim Care Diabetes 2014, 8:57-63. 10.1016/j.pcd.2013.11.010.
7. Harris S.B., Kapor J., Lank C.N., Willan A.R., Houston T. Clinical inertia in patients with T2DM requiring insulin in family practice. Can Fam Physician Médecin Fam Can 2010, 56:e418-e424.
8. Frier B.M. How hypoglycaemia can affect the life of a person with diabetes. Diabetes Metab Res Rev 2008, 24:87-92. 10.1002/dmrr.796.
9. Peyrot M., Barnett A.H., Meneghini L.F., Schumm-Draeger P-M. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med J Br Diabet Assoc 2012, 29:682-689. 10.1111/j.1464-5491.2012.03605.x.
10. 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. Diabetes Care 2008, 31:1112-1117. 10.2337/dc07-1183.
11. Heise T., Nosek L., Rønn B.B., Endahl L., Heinemann L., Kapitza C., et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 2004, 53:1614-1620.
12. Smith-Palmer J., Fajardo-Montañana C., Pollock R.F., Ericsson A., Valentine W.J. Long-term cost-effectiveness of insulin detemir versus NPH insulin in type 2 diabetes in Sweden. J Med Econ 2012, 15:977-986. 10.3111/13696998.2012.692340.
13. Albright E.S., Desmond R., Bell D.S.H. Efficacy of conversion from bedtime NPH insulin injection to once- or twice-daily injections of insulin glargine in type 1 diabetic patients using basal/bolus therapy. Diabetes Care 2004, 27:632-633.
14. Ashwell S.G., Gebbie J., Home P.D. Optimal timing of injection of once-daily insulin glargine in people with type 1 diabetes using insulin lispro at meal-times. Diabet Med 2006, 23:46-52. 10.1111/j. 1464-5491.2005.01726.x.
15. Dhatariya K., Yeong J. Improved glycaemic controls for patients on twice daily dosing regime of insulin glargine compared to those on a once daily dosing regime. Diabetologia 2014, 53:S390.
16. European Medicines Agency Insulin detemir. Summary of product characteristics 2014, 〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000528/WC500036662.pdf〉 (accessed March 2015).
17. European Medicines Agency Insulin glargine. Summary of product characteristics 2014, 〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000284/WC500036082.pdf〉 (accessed March 2015〉.
18. Kilpatrick E.S., Rigby A.S., Goode K., Atkin S.L. Relating mean blood glucose and glucose variability to the risk of multiple episodes of hypoglycaemia in type 1 diabetes. Diabetologia 2007, 50:2553-2561. 10.1007/s00125-007-0820-z.
19. Klein O., Lynge J., Endahl L., Damholt B., Nosek L., Heise T. Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obes Metab 2007, 9:290-299. 10.1111/j.1463-1326.2006.00685.x.
20. Jonassen I., Havelund S., Hoeg-Jensen T., Steensgaard D.B., Wahlund P.O., Ribel U. Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res 2012, 29:2104-2114.
21. Kurtzhals P., Heise T., Strauss H.M., Bottcher S.G., Granhall C., Haahr H., et al. Multi-hexamer formation is the underlying basis for the ultra-long glucose-lowering effect of insulin degludec. Diabetologia 2011, 54(suppl. 1):S426.
22. Unnikrishnan A.G., Bantwal G., Sahay R.K. Translating structure to clinical properties of an ideal basal insulin. J Assoc Physicians India 2014, 62:15-20.
23. Mühlig P., Klupsch T., Kaulmann U., Hilgenfeld R. Noninvasive in situ observation of the crystallization kinetics of biological macromolecules by confocal laser scanning microscopy. J Struct Biol 2003, 142:47-55.
24. Heise T., Nosek L., Bøttcher S.G., Hastrup H., Haahr H. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab 2012, 14:944-950.
25. Nosek L., Coester H-V., Roepstorff C., Thomsen H.F., Kristensen N.R., Haahr H., et al. Glucose-lowering effect of insulin degludec is independent of subcutaneous injection region. Clin Drug Investig 2014, 34:673-679. 10.1007/s40261-014-0218-x.
26. Heise T., Hermanski L., Nosek L., Feldman 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. 10.1111/j.1463-1326.2012.01627.x.
27. Lepore M., Pampanelli S., Fanelli C., Porcellati F., Bartocci L., Di Vincenzo A., et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes 2000, 49:2142-2148.
28. Haahr H., Ikushima I., Hirao K., Kiyomi F., Heise T. Similar pharmacokinetic and pharmacodynamic properties of insulin degludec in Japanese and Caucasian subjects with T1DM. J Diabetes Investig 2012, 3:197.
29. Coester H-V., Heise T., Nosek L., Roepstorff C., Segel S., Lassota N. Steady state is reached within two to three days of once-daily administration of ultra-long-acting insulin degludec. Diabetologia 2012, 55:S373.
30. Kiss I., Arold G., Roepstorff C., Bøttcher S.G., Klim S., Haahr H. Insulin degludec: pharmacokinetics in patients with renal impairment. Clin Pharmacokinet 2014, 53:175-183. 10.1007/s40262-013-0113-2.
31. Korsatko S., Deller S., Mader J.K., Glettler K., Koehler G., Treiber G., et al. Ultra-long pharmacokinetic properties of insulin degludec are comparable in elderly subjects and younger adults with type 1 diabetes mellitus. Drugs Aging 2014, 31:47-53. 10.1007/s40266-013-0138-0.
32. Kupčová V., Arold G., Roepstorff C., Højbjerre M., Klim S., Haahr H. Insulin degludec: pharmacokinetic properties in subjects with hepatic impairment. Clin Drug Investig 2014, 34:127-133. 10.1007/s40261-013-0154-1.
33. Korsatko S., Deller S., Koehler G., Mader J.K., Neubauer K., Adrian C.L., et al. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig 2013, 33:515-521.
34. European Medicines Agency Insulin degludec. Summary of product characteristics 2013, 〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002498/WC500138940.pdf〉 (accessed March 2015〉.
35. Heise T., Nosek L., Roepstorff C., Chenji S., Klein O., Haahr H. Distinct prandial and basal glucose-lowering effects of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes mellitus. Diabetes Ther 2014, 5:255-265. 10.1007/s13300-014-0070-2.
36. European Medicines Agency Ryzodeg summary of product characteristics 2014, Available at 〈http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002499/human_med_001608.jsp&mid=WC0b01ac058001d124〉 (accessed March 2015〉.
37. Fulcher G.R., Christiansen J.S., Bantwal G., Polaszewska-Muszynska M., Mersebach H., Andersen T.H., et al. Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care 2014, 37:2084-2090. 10.2337/dc13-2908.
38. Niskanen L., Leiter L.A., Franek E., Weng J., Damci T., Muñoz-Torres M., et al. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol Eur Fed Endocr Soc 2012, 167:287-294. 10.1530/EJE-12-0293.
39. Onishi Y., Ono Y., Rabøl R., Endahl L., Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab 2013, 15:826-832. 10.1111/dom.12097.
40. Hirsch I.B., Bode B., Courreges J-P., Dykiel P., Franek E., Hermansen K., et al. Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial. Diabetes Care 2012, 35:2174-2181. 10.2337/dc11-2503.
41. Baggio L.L., Drucker D.J. Biology of incretins: GLP-1 and GIP. Gastroenterology 2007, 132:2131-2157. 10.1053/j.gastro.2007.03.054.
42. Kumar A. Insulin degludec/liraglutide: innovation-driven combination for advancement in diabetes therapy. Expert Opin Biol Ther 2014, 14:869-878. 10.1517/14712598.2014.904851.
43. Buse J.B., Vilsbøll T., Thurman J., Blevins T.C., Langbakke I.H., Bøttcher S.G., et al. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care 2014, 37:2926-2933. 10.2337/dc14-0785.
44. Gough S.C.L., Bode B., Woo V., Rodbard H.W., Linjawi S., Poulsen P., et al. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol 2014, 2:885-893. 10.1016/S2213-8587(14)70174-3.
45. Europe okays Novo Nordisk diabetes combo Xultophy. 2014. Available at 〈http://www.pharmatimes.com/Article/14-09-19/Europe_okays_Novo_Nordisk_diabetes_combo_Xultophy.aspx〉 (accessed March 2015〉.
46. Heller S., Buse J., Fisher M., Garg S., Marre M., Merker L., 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.
47. Mathieu C., Hollander P., Miranda-Palma B., Cooper J., Franek E., Russell-Jones D., et al. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Metab 2013, 98:1154-1162. 10.1210/jc.2012-3249.
48. Onishi Y., Iwamoto Y., Yoo S.J., Clauson P., Tamer S.C., Park S. Insulin degludec compared with insulin glargine in insulin-naïve patients with type 2 diabetes: a 26-week, randomized, controlled, Pan-Asian, treat-to-target trial. J Diabetes Investig 2013, 4:605-612. 10.1111/jdi.12102.
49. Zinman B., Philis-Tsimikas A., Cariou B., Handelsman Y., Rodbard H.W., Johansen T., 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. 10.2337/dc12-1205.
50. Garber A.J., King A.B., Del P.S., Sreenan S., Balci M.K., Munoz-Torres M., 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.
51. Gough S.C.L., Bhargava A., Jain R., Mersebach H., Rasmussen S., Bergenstal R.M. Low-volume insulin degludec 200units/ml once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care 2013, 36:2536-2542. 10.2337/dc12-2329.
52. Meneghini L., Atkin S.L., Gough S.C.L., Raz I., Blonde L., Shestakova M., 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 individuals with type 2 diabetes. Diabetes Care 2013, 36:858-864. 10.2337/dc12-1668.
53. Ratner R.E., Gough S.C.L., 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 2013, 15:175-184. 10.1111/dom.12032.
54. Koehler G., Heller S., Korsatko S., Roepstorff C., Rasmussen S., Haahr H., et al. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossover study. Diabetologia 2014, 57:40-49. 10.1007/s00125-013-3056-0.
55. Bode B., Heise T., Pieber T., Johansen T., Rasmussen S., Russell-Jones D. Higher rates of confirmed hypoglycaemia are associated with greater within-subject variability in fasting blood glucose in type 1 and type 2 diabetes: a meta-analysis. Diabetologia 2013, 56:S423.
56. Meneghini L., Harris S., Evans M., Rasmussen S., Johansen T., Pieber T. Lower within-subject variability in mean blood glucose concentration with insulin degludec vs insulin glargine: a meta-analysis of patients with type 2 diabetes. Diabetologia 2013, 56:S419.
57. Evans M., Ming A., Robinson R. Lessons from early experience with insulin degludec in routine clinical practice 2013, Int. Diabetes Fed., Melbourne, Australia, (p. Poster P1050).
58. McEwan P., Foos V., Evans M. Assessing the real-world cost-effectiveness of switching patients with type 1 diabetes to insulin degludec in routine clinical practice 2013, Int. Diabetes Fed., Melbourne, Australia, (p. Poster P1089).
59. Younk L.M., Mikeladze M., Tate D., Davis S.N. Exercise-related hypoglycemia in diabetes mellitus. Expert Rev Endocrinol Metab 2011, 6:93-108. 10.1586/eem.10.78.
60. Heise T., Zijlstra E., Nosek L., Bracken R., Haahr H., Roepstorff C. Similar risk of exercise-related hypoglycaemia for insulin degludec compared to insulin glargine in patients with type 1 diabetes 2013, Int. Diabetes Fed., Melbourne, Australia, (p. Poster PD0791).
61. Oyer D., Heller S., Gough S., Jensen K., Kinduryte O., Philis-Tsimikas A. Exercise-related hypoglycaemia occurs at similar frequency with insulin degludec and insulin glargine. Diabetologia 2013, 56:S84.
62. Food and Drug Administration Insulin degludec and insulin degludec/insulin aspart treatment to improve glycemic control in patients with diabetes mellitus. Novo nordisk briefing document 2012, Available at 〈http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM327017.pdf〉 〈accessed March 2015〉.
63. ®) compared with insulin glargine in people with type 2 diabetes starting on basal insulin: a meta-analysis of phase 3a trials. Diabet Med 2013, 30:226-232. 10.1111/dme.12086.
64. Home P.D., Meneghini L., Wendisch U., Ratner R.E., Johansen T., Christensen T.E., et al. Improved health status with insulin degludec compared with insulin glargine in people with type 1 diabetes: improved mental health status with degludec compared with glargine in T1D. Diabet Med 2012, 29:716-720. 10.1111/j. 1464-5491.2011.03547.x.
65. Rodbard H., Cariou B., Zinman B., Handelsman Y., Wolden M., Rana A. Physical health status and nocturnal hypoglycemia with insulin degludec vs. insulin glargine: a 2-year trial in insulin-naive patients with type 2 diabetes. Diabetes 2013, 62:A237-A238.
66. Ericsson A. Pollock R.F., Hunt B., Valentine W.J. Evaluation of the cost-utility of insulin degludec vs insulin glargine in Sweden. J Med Econ 2013, 16:1442-1452. 10.3111/13696998.2013.852099.
67. Evans M., Wolden M., Gundgaard J., Chubb B., Christensen T. Cost-effectiveness of insulin degludec compared with insulin glargine for patients with type 2 diabetes treated with basal insulin-from the UK health care cost perspective. Diabetes Obes Metab 2014, 16:366-375.
68. Evans M., Wolden M., Gundgaard J., Chubb B., Christensen T. Cost-effectiveness of insulin degludec compared with insulin glargine in a basal-bolus regimen in patients with type 1 diabetes mellitus in the UK. J Med Econ 2015, 18:56-68. 10.3111/13696998.2014.971160.
69. Home P., Naggar N.E., Khamseh M., Gonzalez-Galvez G., Shen C., Chakkarwar P., et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res Clin Pract 2011, 94:352-363. 10.1016/j.diabres.2011.10.021.
70. Khunti K., Alsifri S., Aronson R., Berković M.C., Enters-Weijnen C., Forsén T., et al. Self-reported hypoglycema: a global study of 24 countries with 27,585 insulin-treated patients with diabetes: the HAT study. Diabetes Res Clin Pract 2014, 106:S105-S106. 10.1016/S0168-8227(14)70412-7.
71. Crasto W., Jarvis J., Hackett E., Nayyar V., McNally P.G., Davies M.J., et al. Insulin U-500 in severe insulin resistance in type 2 diabetes mellitus. Postgrad Med J 2009, 85:219-222. 10.1136/pgmj.2008.073379.
72. Thalange N., Deeb L., Iovota V., Kawamura T., Klingensmith G., Philotheou A. Long-term efficacy and safety of insulin degludec incombination with bolus insulin aspart in children and adolescents with type 1 diabetes. Diabetologia 2014, 57:S395.
73. Philis-Tsimikas A., Del Prato S., Satman I., Bhargava A., Dharmalingam M., Skjøth T.V., et al. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Diabetes Obes Metab 2013, 15:760-766.