The development of new basal insulins: Is there any clinical advantage with their use in type 2 diabetes?

Expert Opinion on Biological Therapy

Volumn 14, Issue 6, 2014, Pages 799-808

  Maiorino, Maria Ida ^a   Petrizzo, Michela ^a   Capuano, Annalisa ^a   Giugliano, Dario ^a   Esposito, Katherine ^a  

^a SECOND UNIVERSITY OF NAPLES   (Italy)

Author keywords

Basal insulin analogues; Clinical advantage; Insulin therapy; Type 2 diabetes

Indexed keywords

AMINOTRANSFERASE; GLARGINE U100; GLARGINE U300; GLUTAMIC ACID; HEMOGLOBIN A1C; HUMAN INSULIN; INSULIN; INSULIN ASPART; INSULIN ASPART PLUS INSULIN DEGLUDEC; INSULIN DEGLUDEC; INSULIN DERIVATIVE; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN PEGLISPRO; ISOPHANE INSULIN; LYSINE; MACROGOL; METFORMIN; ORAL ANTIDIABETIC AGENT; SULFONYLUREA; UNCLASSIFIED DRUG; URETHAN; ANTIDIABETIC AGENT; BIOLOGICAL MARKER; GLARGINE; GLUCOSE BLOOD LEVEL; INSULIN LISPRO; LONG ACTING INSULIN; MACROGOL DERIVATIVE;

AMINOTRANSFERASE BLOOD LEVEL; BLOOD GLUCOSE MONITORING; DRUG ABSORPTION; DRUG CLEARANCE; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; DRUG WITHDRAWAL; EVENING DOSAGE; GLYCEMIC CONTROL; HUMAN; HYDRODYNAMICS; HYPOGLYCEMIA; INSULIN TREATMENT; MORNING DOSAGE; NOCTURNAL HYPOGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PHARMACODYNAMICS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; UNITED STATES; WEIGHT GAIN; ANIMAL; BLOOD; DIABETES MELLITUS, TYPE 2; DRUG DESIGN; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; MEDICINAL CHEMISTRY; METABOLISM; TREATMENT OUTCOME;

ANIMALS; BIOLOGICAL MARKERS; BLOOD GLUCOSE; CHEMISTRY, PHARMACEUTICAL; DIABETES MELLITUS, TYPE 2; DRUG DESIGN; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN LISPRO; INSULIN, LONG-ACTING; INSULINS; POLYETHYLENE GLYCOLS; TREATMENT OUTCOME;

EID: 84900794010     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1517/14712598.2014.895812     Document Type: Review

References (57)

1. Polonsky KS. The past 200 years in diabetes. N Engl J Med 2012;367:1332-40
2. Ullrich A, Shine J, Pictet R, et al. Rat insulin genes: construction of plasmids containing coding sequences. Science 1977;196:1313-19
3. Esposito K, Giugliano D. Current insulin analogues in the treatment of diabetes: emphasis on type 2 diabetes. Expert Opin Biol Ther 2012;12:209-21
4. Esposito K, Capuano A, Giugliano D. Humalog (lispro) for type 2 diabetes. Expert Opin Biol Ther 2012;12:1541-50
5. Zinman B. The physiologic replacement of insulin. An elusive goal. N Engl J Med 1989;321:363-70
6. Inzucchi SE, Bergenstal RM, Buse JB, 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;35:1364-79
7. Davidson MD. Self-mixed/split insulin regimen: a serious omission in the ADA/EASD position statement. Diabetes Care 2014;37:3-4
8. National Diabetes Fact Sheet, 2011. Centers for disease control and prevention. Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta; 2011. Available from: http://www.cdc. gov/diabetes/pubs/factsheet11.htm
9. Turner LW, Nartey D, Stafford RS, et al. Ambulatory treatment of type 2 diabetes in the United States, 1997-2012. Diabetes Care 2013. [Epub ahead of print]
10. The AMD Annals 2009 Working Group. Longitudinal analysis of quality indicators of diabetes care in Italy ( 2004- 2007). Associazione Medici Diabetologi, Rome; 2009. Available from: http://www.infodiabetes.it/files/ ANNALI-AMD/2010/Annali%202010%20inglese.pdf
11. Khunti K, Wolden ML, Thorsted BL, et al. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80, 000 people. Diabetes Care 2013;36:3411-17
12. Giugliano D, Esposito K. Clinical inertia as a clinical safeguard. JAMA 2011;305:1591-2
13. DeVries JH, Nattrass M, Pieber TR. Refining basal insulin therapy: what have we learned in the age of analogues? Diabetes Metab Res Rev 2007;23:441-54
14. Singh SR, Ahmad F, Lal A, et al. Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis. CMAJ 2009;180:385-97
15. Waugh N, Cummins E, Royle P, et al. Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation. Health Technol Assess 2010;14:1-248
16. Frier BM. How hypoglycaemia can affect the life of a person with diabetes. Diabetes Metab Res Rev 2008;24:87-92
17. Brod M, Christensen T, Thomsen TL, Bushnell DM. The impact of non-severe hypoglycemic events on work productivity and diabetes management. Value Health 2011;14:665-71
18. Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med 2012;29:682-9
19. Giugliano D, Maiorino MI, Bellastella G, et al. Treatment regimens with insulin analogues and haemoglobin A1c target of < 7% in type 2 diabetes: a systematic review. Diabetes Res Clin Pract 2011;92:1-10
20. Garber AJ. Will the next generation of basal insulins offer clinical advantages? Diabetes Obes Metab 2013. [Epub ahead of print]
21. Owens DR, Matfin G, Monnier L. Basal insulin analogues in the management of diabetes mellitus: what progress have we made? Diabetes Metab Res Rev 2014;30:104-19
22. Rossetti P, Ampudia-Blasco FJ, Ascaso JF. Old and new basal insulin formulations: understanding pharmacodynamics is still relevant in clinical practice. Diabetes Obes Metab 2014, doi:10.1111/dom.12256
23. Heise T, Nosek L, Bottcher SG, et al. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab 2012;14:944-50
24. Jonassen I, Havelund S, Hoeg-Jensen T, et al. Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res 2012;29:2104-14
25. Nishimura E, Sørensen AR, Hansen BF, et al. Insulin degludec: a new ultra-long, basal insulin designed to maintain full metabolic effect while minimizing mitogenic potential (Abstract 974). Diabetologia 2010;53(Suppl 1):S388-9
26. 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;35:2464-71
27. Onishi Y, Iwamoto K, Yoo SJ, et al. 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 Invest 2013;4:605-12
28. Meneghini L, Atkin SL, Gough SC, 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;36:858-64
29. Gough SC, Bhargava A, Jain R, et al. Low-volume insulin degludec 200 units/ml once daily improves glycemic control similar 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;36:2536-42
30. Zinman B, DeVries JH, Bode B, et al. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol 2013;1:123-31
31. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Assessment Report for Tresiba (insulin degludec). 2012. Available from: http://www.ema. europa.eu/docs/en-GB/document-library/EPAR-Public-assessment- report/human/002498/WC500139010.pdf
32. Koehler G, Heller S, Korsatko S, et al. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a doubleblind randomised crossover study. Diabetologia 2014;57:40-9
33. Rodbard HW, Cariou B, Zinman B, et al. BEGIN Once Long trial investigators. Comparison of insulin degludec with insulin glargine in insulinnaive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabet Med 2013;30:1298-304
34. Meneghini LF, Harris SB, Evans M, et al. Lower within-subject variability in mean blood glucose concentration with insulin degludec vs insulin glargine: a meta-analysis of patients with type 2 diabetes (Conference abstract). Diabetologia 2013;56(Suppl 1):S419
35. FDA. Endocrinologic and Metabolic Drugs Advisory Committee Meeting. 2012. Available from: http://www.fda. gov/downloads/advisorycommittees/ committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsad visorycommittee/ucm330923.pdf
36. Arold G, Kupcova V, Thrane M, et al. Insulin degludec has similar pharmacokinetic properties in subjects with hepatic impairment when compared to subjects with normal hepatic function [abstract 1119-P]. Diabetes 2012;61(Suppl 1):A289
37. Kiss I, Arold G, Bøttcher SG, et al. Insulin degludec has similar pharmacokinetic properties in subjects with renal impairment and subjects with normal renal function [abstract 1151-P]. Diabetes 2012;61(Suppl 1):A296-7
38. Niskanen L, Leiter LA, Franek E, 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 2012;167:287-94
39. Schmidt TA, Rosen CJ, Yudkin JS. European Medicines Agency must take account of cardiovascular harm associated with degludec insulin. BMJ 2013;346:f3731
40. Caparrotta TM, Evans M. PEGylated insulin Lispro, (LY2605541)-a new basal insulin analogue. Diabetes Obes Metab 2013. [Epub ahead of print]
41. Hansen RJ, Cutler GB, Vick A, et al. LY2605541: leveraging hydrodynamic size to develop a novel basal insulin. Diabetes 2012;61(Suppl 1):A228
42. Beals JM, Cutler GB, Vick A, et al. LY2605541: leveraging hydrodynamic size to develop a novel basal insulin (Conference Abstract). Diabetologia 2012;55(Suppl 1):S23
43. Sinha VP, Choi SL, Soon DK, et al. Single-dose pharmacokinetics and glucodynamics of the novel long-acting basal insulin LY2605541 in healthy subjects. J Clin Pharmacol 2014, doi:10.1002/jcph.276
44. Owens RA, Lockwood JF, Dunbar JD, et al. In vitro characterization of novel basal insulin LY2605541: reduced mitogenicity and IGF-IR binding. Diabetes 2012;61(Suppl 1):A425
45. Moore MC, Smith MS, Mace KF, et al. Novel pegylated basal insulin LY2605541 has a preferential hepatic effect on glucose metabolism. Diabetes 2014;63:494-504
46. Madsbad S. LY2605541-A preferential hepato-specific insulin analogue. Diabetes 2014;63:390-2
47. Linnebjerg H, Choi SL, Lam EQC, et al. Pharmacokinetics (PK) of the novel, long-acting basal insulin LY2605541 in subjects with varying degrees of renal function. Diabetes 2012;61(Suppl 1):A296
48. Bergenstal RM, Rosenstock J, Arakaki RF, et al. A randomized, controlled study of once-daily LY2605541, a novel long-acting basal insulin, vs. insulin glargine in basal insulin-treated patients with type 2 diabetes. Diabetes Care 2012;35:2140-7
49. Bergenstal RM, Rosenstock J, Bastyr EJ III, et al. Lower glucose variability and hypoglycemia measured by continuous glucose monitoring with novel long-acting insulin LY2605541 versus insulin glargine. Diabetes Care 2013, doi:10.2337/dc12-2621
50. Rosenstock J, Bergenstal RM, Blevins TC, et al. Better glycemic control and weight loss with the novel long-acting basal insulin LY2605541 compared with insulin glargine in type 1 diabetes a randomized, crossover study. Diabetes Care 2012;36:522-8
51. Jacober SJ, Rosenstock J, Bergenstal RM, et al. Contrasting weight changes with LY2605541, a novel long-acting insulin, and insulin glargine despite similar improved glycaemic control in type 1 diabetes and type 2 diabetes (Conference Abstract). Diabetologia 2012;55(Suppl 1):S377
52. Tillner J, Bergmann K, Teichert L, et al. Euglycemic clamp profile of new insulin glargine U300 formulation in patients with Type 1 Diabetes (T1DM) is different from glargine U100 (Abstract 920-P). Diabetes 2013;62(Suppl 1):A234
53. Riddle MC, Bolli GB, Ziemen M, et al. New insulin glargine formulation: glucose control and hypoglycemia in people with type 2 diabetes using basal and mealtime insulin (EDITION I) (Abstract 43-LB). Diabetes 2013;62(Suppl 1A):LB12
54. Sanofi. Sanofi announces positive Phase 3 results for investigational new insulin U300. Press release, 22 June 2013. Available from: http://en.sanofi. com/Images/33225-20130622-EDITION-I-and-II-ADA-en.pdf
55. Esposito K, Chiodini P, Capuano A, et al. Basal supplementation of insulin lispro protamine suspension versus insulin glargine and detemir for type 2 diabetes: meta-analysis of randomized controlled trials. Diabetes Care 2012;35:2698-705
56. Hitman GA. Degludec: a new insulin for today? Diabet Med 2013;30:1267
57. Evans M, Wolden M, Gundgaard J, et al. 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 2013. [Epub ahead of print]