Skip to main content
Erschienen in: Drugs 6/2013

01.05.2013 | Adis Drug Evaluation

Insulin Degludec and Insulin Degludec/Insulin Aspart: A Review of Their Use in the Management of Diabetes Mellitus

verfasst von: Gillian M. Keating

Erschienen in: Drugs | Ausgabe 6/2013

Einloggen, um Zugang zu erhalten

Abstract

Insulin degludec (Tresiba®) is an ultra-long-acting insulin analogue that is also available as a coformulation with rapid-acting insulin aspart (insulin degludec/insulin aspart) [Ryzodeg®]. Insulin degludec has a flat, stable glucose-lowering profile with a duration of action of >42 h, and less within-patient day-to-day variability in glucose-lowering effect than the long-acting insulin analogue insulin glargine. In clinical trials, insulin degludec achieved similar glycaemic control to that seen with insulin glargine in patients with type 1 or 2 diabetes, but with a lower risk of nocturnal hypoglycaemia. In addition, trials examining a flexible dosing regimen of insulin degludec in patients with type 1 or 2 diabetes show the potential for adjusting the injection time, without compromising glycaemic control or safety. A 200 U/mL formulation of insulin degludec is also available for use in patients who require large volumes of basal insulin. Insulin degludec/insulin aspart was noninferior to the long-acting insulin analogue insulin detemir in patients with type 1 diabetes and has the potential to reduce the number of daily injections. Trial results also indicate that insulin degludec/insulin aspart may be an appropriate option for initiating insulin therapy in patients with type 2 diabetes inadequately controlled with oral antidiabetic drugs. Subcutaneous insulin degludec was generally well tolerated in patients with type 1 or 2 diabetes. In conclusion, insulin degludec and insulin degludec/insulin aspart represent a useful advance in the treatment of type 1 or 2 diabetes.
Literatur
1.
Zurück zum Zitat Skyler JS, Bergenstal R, Bonow RO, et al. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA Diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care. 2009;32(1):187–92.PubMedCrossRef Skyler JS, Bergenstal R, Bonow RO, et al. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA Diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care. 2009;32(1):187–92.PubMedCrossRef
2.
Zurück zum Zitat American Diabetes Association. Standard of medical care in diabetes: 2013. Diabetes Care. 2013;36(Suppl 1):S11–66.CrossRef American Diabetes Association. Standard of medical care in diabetes: 2013. Diabetes Care. 2013;36(Suppl 1):S11–66.CrossRef
3.
Zurück zum Zitat Heise T, Pieber TR. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes Obes Metab. 2007;9(5):648–59.PubMedCrossRef Heise T, Pieber TR. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes Obes Metab. 2007;9(5):648–59.PubMedCrossRef
4.
Zurück zum Zitat Arnolds S, Kuglin B, Kapitza C, et al. How pharmacokinetic and pharmacodynamic principles pave the way for optimal basal insulin therapy in type 2 diabetes. Int J Clin Pract. 2010;64(10):1415–24.PubMedCrossRef Arnolds S, Kuglin B, Kapitza C, et al. How pharmacokinetic and pharmacodynamic principles pave the way for optimal basal insulin therapy in type 2 diabetes. Int J Clin Pract. 2010;64(10):1415–24.PubMedCrossRef
5.
Zurück zum Zitat Peterson GE. Intermediate and long-acting insulins: a review of NPH insulin, insulin glargine and insulin detemir. Curr Med Res Opin. 2006;22(12):2613–9.PubMedCrossRef Peterson GE. Intermediate and long-acting insulins: a review of NPH insulin, insulin glargine and insulin detemir. Curr Med Res Opin. 2006;22(12):2613–9.PubMedCrossRef
6.
Zurück zum Zitat Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with type 1 diabetes using meal-time insulin aspart. Diabet Med. 2006;23(8):879–86.PubMedCrossRef Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with type 1 diabetes using meal-time insulin aspart. Diabet Med. 2006;23(8):879–86.PubMedCrossRef
9.
Zurück zum Zitat Jonassen IB, 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 no. 39-OR]. 70th Annual Scientific Sessions of the American Diabetes Association; Orlando, FL; 25–29 June 2010. Jonassen IB, 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 no. 39-OR]. 70th Annual Scientific Sessions of the American Diabetes Association; Orlando, FL; 25–29 June 2010.
10.
Zurück zum Zitat Kurtzhals P, Heise T, Strauss HM, et al. Multi-hexamer formation is the underlying basis for the ultra-long glucose-lowering effect of insulin degludec [abstract no. 1049]. Diabetologia. 2011;54(Suppl 1):S426. Kurtzhals P, Heise T, Strauss HM, et al. Multi-hexamer formation is the underlying basis for the ultra-long glucose-lowering effect of insulin degludec [abstract no. 1049]. Diabetologia. 2011;54(Suppl 1):S426.
11.
Zurück zum Zitat Seested T, Havelund S, Jonassen IB, et al. Ultrastructural visualisation of insulin degludec multi-hexamers in the subcutaneous depot in vivo supports a unique mechanism of protraction [abstract no. 980-P]. Diabetes. 2012;61(Suppl 1):A250. Seested T, Havelund S, Jonassen IB, et al. Ultrastructural visualisation of insulin degludec multi-hexamers in the subcutaneous depot in vivo supports a unique mechanism of protraction [abstract no. 980-P]. Diabetes. 2012;61(Suppl 1):A250.
12.
Zurück zum Zitat Jonassen I, Hoeg-Jensen T, Havelund S, et al. Ultra-long acting insulin degludec can be combined with rapid-acting insulin aspart in a soluble co-formulation [abstract no 380]. J Pept Sci. 2010;16(Suppl 1):32. Jonassen I, Hoeg-Jensen T, Havelund S, et al. Ultra-long acting insulin degludec can be combined with rapid-acting insulin aspart in a soluble co-formulation [abstract no 380]. J Pept Sci. 2010;16(Suppl 1):32.
13.
Zurück zum Zitat 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 no. 974]. Diabetologia. 2010;53(Suppl 1):S388–9. 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 no. 974]. Diabetologia. 2010;53(Suppl 1):S388–9.
14.
Zurück zum Zitat Nosek L, Coester H-V, Thomsen HF, et al. Glucose-lowering effect of insulin degludec is independent of subcutaneous injection region [abstract no. 899-P]. Diabetes. 2012;61(Suppl 1):A228. Nosek L, Coester H-V, Thomsen HF, et al. Glucose-lowering effect of insulin degludec is independent of subcutaneous injection region [abstract no. 899-P]. Diabetes. 2012;61(Suppl 1):A228.
15.
Zurück zum Zitat Korsatko S, Deller S, Zahiragic S, et al. Ultra-long-acting insulin degludec: two different formulations (U100 and U200) are bioequivalent and show similar pharmacodynamics [abstract no. 2349-PO]. Diabetes. 2011;60 Suppl:A624. Korsatko S, Deller S, Zahiragic S, et al. Ultra-long-acting insulin degludec: two different formulations (U100 and U200) are bioequivalent and show similar pharmacodynamics [abstract no. 2349-PO]. Diabetes. 2011;60 Suppl:A624.
16.
Zurück zum Zitat Hövelmann U, Heise T, Nosek L, et al. Insulin degludec 200 U/ml is ultra-long-acting and has a flat and stable glucose-lowering effect [abstract no. 912]. Diabetologia. 2012;55(Suppl 1):S374–5. Hövelmann U, Heise T, Nosek L, et al. Insulin degludec 200 U/ml is ultra-long-acting and has a flat and stable glucose-lowering effect [abstract no. 912]. Diabetologia. 2012;55(Suppl 1):S374–5.
17.
Zurück zum Zitat Heise T, Nosek L, Bøttcher 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(10):944–50.PubMedCrossRef Heise T, Nosek L, Bøttcher 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(10):944–50.PubMedCrossRef
18.
Zurück zum Zitat Nasrallah SN, Reynolds LR. Insulin degludec, the new generation basal insulin or just another basal insulin? Clin Med Insights Endocrinol Diabetes. 2012;5:31–7.PubMedCrossRef Nasrallah SN, Reynolds LR. Insulin degludec, the new generation basal insulin or just another basal insulin? Clin Med Insights Endocrinol Diabetes. 2012;5:31–7.PubMedCrossRef
19.
Zurück zum Zitat Steensgaard DB, Schluckebier G, Strauss HM, et al. Ligand-controlled assembly of hexamers, dihexamers, and linear multihexamer structures by the engineered acylated insulin degludec. Biochemistry (Moscow). 2013;52(2):295–309.CrossRef Steensgaard DB, Schluckebier G, Strauss HM, et al. Ligand-controlled assembly of hexamers, dihexamers, and linear multihexamer structures by the engineered acylated insulin degludec. Biochemistry (Moscow). 2013;52(2):295–309.CrossRef
20.
Zurück zum Zitat 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(8):2104–14.PubMedCrossRef 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(8):2104–14.PubMedCrossRef
21.
Zurück zum Zitat Robinson JD, Neumiller JJ, Campbell RK. Can a new ultra-long acting insulin analog improve patient care? Investigating the potential role of insulin degludec. Drugs. 2012;72(18):2319–25.PubMedCrossRef Robinson JD, Neumiller JJ, Campbell RK. Can a new ultra-long acting insulin analog improve patient care? Investigating the potential role of insulin degludec. Drugs. 2012;72(18):2319–25.PubMedCrossRef
22.
Zurück zum Zitat Hirsch IB, Bode B, Courreges J-P, 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(11):2174–81.PubMedCrossRef Hirsch IB, Bode B, Courreges J-P, 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(11):2174–81.PubMedCrossRef
24.
Zurück zum Zitat Heise T, Hermanski L, Nosek L, et al. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012;14(9):859–64.PubMedCrossRef Heise T, Hermanski L, Nosek L, et al. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012;14(9):859–64.PubMedCrossRef
25.
Zurück zum Zitat Reynolds NA, Wagstaff AJ. Insulin aspart: a review of its use in the management of type 1 or 2 diabetes mellitus. Drugs. 2004;64(17):1957–74.PubMedCrossRef Reynolds NA, Wagstaff AJ. Insulin aspart: a review of its use in the management of type 1 or 2 diabetes mellitus. Drugs. 2004;64(17):1957–74.PubMedCrossRef
26.
Zurück zum Zitat Heise T, Hövelmann U, Nosek L, et al. Insulin degludec: two-fold longer half-life and a more consistent pharmacokinetic profile than insulin glargine [abstract no. 1046]. Diabetologia. 2011;54(Suppl 1):S425. Heise T, Hövelmann U, Nosek L, et al. Insulin degludec: two-fold longer half-life and a more consistent pharmacokinetic profile than insulin glargine [abstract no. 1046]. Diabetologia. 2011;54(Suppl 1):S425.
27.
Zurück zum Zitat Haahr HL, Arold G, Bottcher SG, et al. Insulin degludec has similar pharmacokinetic properties in subjects with renal impairment and subjects with normal renal function [abstract no. 923]. Diabetologia. 2012;55(Suppl 1):S379. Haahr HL, Arold G, Bottcher SG, et al. Insulin degludec has similar pharmacokinetic properties in subjects with renal impairment and subjects with normal renal function [abstract no. 923]. Diabetologia. 2012;55(Suppl 1):S379.
28.
Zurück zum Zitat Arold G, Kupčová 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 no. 1119-P]. Diabetes. 2012;61 Suppl:A289. Arold G, Kupčová 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 no. 1119-P]. Diabetes. 2012;61 Suppl:A289.
29.
Zurück zum Zitat Danne T, Biester T, Blaesig S, et al. Ultra-long pharmacokinetic properties of insulin degludec in adults with type 1 diabetes is preserved in children and adolescents after single-dose administration [abstract no. 1047]. Diabetologia. 2011;54(Suppl 1):S425–6. Danne T, Biester T, Blaesig S, et al. Ultra-long pharmacokinetic properties of insulin degludec in adults with type 1 diabetes is preserved in children and adolescents after single-dose administration [abstract no. 1047]. Diabetologia. 2011;54(Suppl 1):S425–6.
30.
Zurück zum Zitat Korsatko S, Deller S, Mader J, et al. Ultra-long pharmacokinetic properties of insulin degludec in younger adults are preserved in geriatric subjects with type 1 diabetes [abstract no. 924]. Diabetologia. 2012;55(Suppl 1):S379–80. Korsatko S, Deller S, Mader J, et al. Ultra-long pharmacokinetic properties of insulin degludec in younger adults are preserved in geriatric subjects with type 1 diabetes [abstract no. 924]. Diabetologia. 2012;55(Suppl 1):S379–80.
31.
Zurück zum Zitat Hompesch M, Morrow L, Watkins E, et al. Insulin degludec provides similar pharmacokinetic and pharmacodynamic responses in Black, White and Hispanic/Latino patients with type 2 diabetes [abstract no. 925]. Diabetologia. 2012;55(Suppl 1):S380. Hompesch M, Morrow L, Watkins E, et al. Insulin degludec provides similar pharmacokinetic and pharmacodynamic responses in Black, White and Hispanic/Latino patients with type 2 diabetes [abstract no. 925]. Diabetologia. 2012;55(Suppl 1):S380.
33.
Zurück zum Zitat Bergenstal R, Bhargava A, Jain R, 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 [abstract no. 207]. American Association of Clinical Endocrinologists 21st Annual Scientific and Clinical Congress; Philadelphia, PA; 23–27 May 2012. Bergenstal R, Bhargava A, Jain R, 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 [abstract no. 207]. American Association of Clinical Endocrinologists 21st Annual Scientific and Clinical Congress; Philadelphia, PA; 23–27 May 2012.
34.
Zurück zum Zitat Birkeland KI, Home PD, Wendisch U, 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(3):661–5.PubMedCrossRef Birkeland KI, Home PD, Wendisch U, 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(3):661–5.PubMedCrossRef
35.
Zurück zum Zitat Zinman B, Fulcher G, Rao PV, 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(9769):924–31.PubMedCrossRef Zinman B, Fulcher G, Rao PV, 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(9769):924–31.PubMedCrossRef
36.
Zurück zum Zitat 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(9825):1489–97.PubMedCrossRef 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(9825):1489–97.PubMedCrossRef
37.
Zurück zum Zitat Mathieu C, Hollander P, Miranda-Palma B, 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(3):1154–62.PubMedCrossRef Mathieu C, Hollander P, Miranda-Palma B, 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(3):1154–62.PubMedCrossRef
38.
Zurück zum Zitat Onishi Y, Park SW, Yoo SJ, et al. Insulin degludec improves glycemic control in insulin-naïve patients with type 2 diabetes: results of a randomized pan-Asian trial [abstract no. 1059-P]. Diabetes. 2012;61(Suppl 1):A272. Onishi Y, Park SW, Yoo SJ, et al. Insulin degludec improves glycemic control in insulin-naïve patients with type 2 diabetes: results of a randomized pan-Asian trial [abstract no. 1059-P]. Diabetes. 2012;61(Suppl 1):A272.
39.
Zurück zum Zitat 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(12):2464–71.PubMedCrossRef 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(12):2464–71.PubMedCrossRef
40.
Zurück zum Zitat 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(9825):1498–507.PubMedCrossRef 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(9825):1498–507.PubMedCrossRef
41.
Zurück zum Zitat Philis-Tsimikas A, Del Prato S, Satman I, et al. Insulin degludec is superior to sitagliptin in improving glycaemic control in uncontrolled patients with type 2 diabetes on oral agents [abstract no. 40]. Diabetologia. 2012;55(Suppl 1):S22. Philis-Tsimikas A, Del Prato S, Satman I, et al. Insulin degludec is superior to sitagliptin in improving glycaemic control in uncontrolled patients with type 2 diabetes on oral agents [abstract no. 40]. Diabetologia. 2012;55(Suppl 1):S22.
42.
Zurück zum Zitat 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 people with type 2 diabetes. Diabetes Care. 2013;36(4):858–64.PubMedCrossRef 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 people with type 2 diabetes. Diabetes Care. 2013;36(4):858–64.PubMedCrossRef
43.
Zurück zum Zitat Rodbard HW, Handelsman Y, Cariou B, et al. Insulin degludec reduces hypoglycemia and improves health status vs. insulin glargine in insulin-naïve type 2 diabetes [abstract no. 1192-P]. Diabetes. 2012;61(Suppl 1):A307–8. Rodbard HW, Handelsman Y, Cariou B, et al. Insulin degludec reduces hypoglycemia and improves health status vs. insulin glargine in insulin-naïve type 2 diabetes [abstract no. 1192-P]. Diabetes. 2012;61(Suppl 1):A307–8.
44.
Zurück zum Zitat Rodbard HW, Zinman B, Cariou B, et al. Reduced nocturnal hypoglycaemia with insulin degludec as compared to insulin glargine: results of a 2-year randomised trial in type 2 diabetes [abstract no. 920]. Diabetologia. 2012;55(Suppl 1):S378. Rodbard HW, Zinman B, Cariou B, et al. Reduced nocturnal hypoglycaemia with insulin degludec as compared to insulin glargine: results of a 2-year randomised trial in type 2 diabetes [abstract no. 920]. Diabetologia. 2012;55(Suppl 1):S378.
45.
Zurück zum Zitat Novo Nordisk. Comparison of NN1250 with sitagliptin in subjects with type 2 diabetes never treated with insulin [ClinicalTrials.gov identifier NCT01046110]. US National Institutes of Health, ClinicalTrials.gov (online). 2011. http://www.clinicaltrials.gov. Accessed 13 Nov 2012. Novo Nordisk. Comparison of NN1250 with sitagliptin in subjects with type 2 diabetes never treated with insulin [ClinicalTrials.gov identifier NCT01046110]. US National Institutes of Health, ClinicalTrials.gov (online). 2011. http://​www.​clinicaltrials.​gov. Accessed 13 Nov 2012.
46.
Zurück zum Zitat Novo Nordisk. Comparison of NN1250 versus insulin glargine in subjects with type 2 diabetes (BEGIN™) [ClinicalTrials.gov identifier NCT01059799]. US National Institutes of Health, ClinicalTrials.gov (online). 2011. http://www.clinicaltrials.gov. Accessed 13 Nov 2012. Novo Nordisk. Comparison of NN1250 versus insulin glargine in subjects with type 2 diabetes (BEGIN™) [ClinicalTrials.gov identifier NCT01059799]. US National Institutes of Health, ClinicalTrials.gov (online). 2011. http://​www.​clinicaltrials.​gov. Accessed 13 Nov 2012.
47.
Zurück zum Zitat Novo Nordisk. Comparison of NN1250 with insulin glargine in subjects with type 2 diabetes (BEGIN™) [ClinicalTrials.gov identifier NCT01068665]. US National Institutes of Health, ClinicalTrials.gov (online). 2011. http://www.clinicaltrials.gov. Accessed 15 Nov 2012. Novo Nordisk. Comparison of NN1250 with insulin glargine in subjects with type 2 diabetes (BEGIN™) [ClinicalTrials.gov identifier NCT01068665]. US National Institutes of Health, ClinicalTrials.gov (online). 2011. http://​www.​clinicaltrials.​gov. Accessed 15 Nov 2012.
48.
Zurück zum Zitat Freemantle N, Meneghini L, Christensen T, et al. 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. Diabet Med. 2013;30(2):226–32.PubMedCrossRef Freemantle N, Meneghini L, Christensen T, et al. 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. Diabet Med. 2013;30(2):226–32.PubMedCrossRef
49.
Zurück zum Zitat 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-naïve people with type 2 diabetes: a randomized, controlled trial. Diabetes Care. 2011;34(3):669–74.PubMedCrossRef 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-naïve people with type 2 diabetes: a randomized, controlled trial. Diabetes Care. 2011;34(3):669–74.PubMedCrossRef
50.
Zurück zum Zitat Nakamura S, Ono Y, Rabøl R, et al. Superior glycaemic control with once-daily IDegAsp vs insulin glargine in Japanese adults with type 2 diabetes mellitus inadequately controlled with OADs: a randomised controlled, phase 3 trial [abstract no. 949]. Diabetologia. 2012;55(Suppl 1):S390. Nakamura S, Ono Y, Rabøl R, et al. Superior glycaemic control with once-daily IDegAsp vs insulin glargine in Japanese adults with type 2 diabetes mellitus inadequately controlled with OADs: a randomised controlled, phase 3 trial [abstract no. 949]. Diabetologia. 2012;55(Suppl 1):S390.
51.
Zurück zum Zitat 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(2):287–94.PubMed 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(2):287–94.PubMed
52.
Zurück zum Zitat Novo Nordisk. Comparison of NN5401 with insulin glargine in insulin naive subjects with type 2 diabetes (BOOST™) [ClinicalTrials.gov identifier NCT01272193]. US National Institutes of Health, ClinicalTrials.gov (online). 2012. http://www.clinicaltrials.gov. Accessed 15 Nov 2012. Novo Nordisk. Comparison of NN5401 with insulin glargine in insulin naive subjects with type 2 diabetes (BOOST™) [ClinicalTrials.gov identifier NCT01272193]. US National Institutes of Health, ClinicalTrials.gov (online). 2012. http://​www.​clinicaltrials.​gov. Accessed 15 Nov 2012.
54.
Zurück zum Zitat Ratner R, Gough SCL, Mathieu C, et al. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013;15(2):175–84.PubMedCrossRef Ratner R, Gough SCL, Mathieu C, et al. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013;15(2):175–84.PubMedCrossRef
55.
Zurück zum Zitat Muggeo M, Verlato G, Bonora E, et al. Long-term instability of fasting plasma glucose, a novel predictor of cardiovascular mortality in elderly patients with non-insulin-dependent diabetes mellitus: the Verona Diabetes Study. Circulation. 1997;96(6):1750–4.PubMedCrossRef Muggeo M, Verlato G, Bonora E, et al. Long-term instability of fasting plasma glucose, a novel predictor of cardiovascular mortality in elderly patients with non-insulin-dependent diabetes mellitus: the Verona Diabetes Study. Circulation. 1997;96(6):1750–4.PubMedCrossRef
57.
Zurück zum Zitat Wakil A, Atkin SL. Efficacy and safety of ultra-long-acting insulin degludec. Ther Adv Endocrinol Metab. 2012;3(2):55–9.PubMedCrossRef Wakil A, Atkin SL. Efficacy and safety of ultra-long-acting insulin degludec. Ther Adv Endocrinol Metab. 2012;3(2):55–9.PubMedCrossRef
58.
Zurück zum Zitat American Diabetes Association Workgroup on Hypoglycemia. Defining and reporting hypoglycaemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005;28(5):1245–9.CrossRef American Diabetes Association Workgroup on Hypoglycemia. Defining and reporting hypoglycaemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005;28(5):1245–9.CrossRef
60.
Zurück zum Zitat Tahrani AA, Bailey CJ, Barnett AH. Insulin degludec: a new ultra-longacting insulin. Lancet. 2012;379(9825):1465–7.PubMedCrossRef Tahrani AA, Bailey CJ, Barnett AH. Insulin degludec: a new ultra-longacting insulin. Lancet. 2012;379(9825):1465–7.PubMedCrossRef
61.
Zurück zum Zitat Keating GM. Insulin detemir: a review of its use in the management of diabetes mellitus. Drugs. 2012;72(17):2255–87.PubMedCrossRef Keating GM. Insulin detemir: a review of its use in the management of diabetes mellitus. Drugs. 2012;72(17):2255–87.PubMedCrossRef
65.
Zurück zum Zitat Giovannucci E, Harlan DM, Archer MC, et al. Diabetes and cancer: a consensus report. Diabetes Care. 2010;33(7):1674–85.PubMedCrossRef Giovannucci E, Harlan DM, Archer MC, et al. Diabetes and cancer: a consensus report. Diabetes Care. 2010;33(7):1674–85.PubMedCrossRef
66.
Zurück zum Zitat Dejgaard A, Lynggaard H, Råstam J, et al. No evidence of increased risk of malignancies in patients with diabetes treated with insulin detemir: a meta-analysis. Diabetologia. 2009;52(12):2507–12.PubMedCrossRef Dejgaard A, Lynggaard H, Råstam J, et al. No evidence of increased risk of malignancies in patients with diabetes treated with insulin detemir: a meta-analysis. Diabetologia. 2009;52(12):2507–12.PubMedCrossRef
67.
Zurück zum Zitat Evans M, Schumm-Draeger PM, Vora J, et al. A review of modern insulin analogue pharmacokinetic and pharmacodynamic profiles in type 2 diabetes: improvements and limitations. Diabetes Obes Metab. 2011;13(8):677–84.PubMedCrossRef Evans M, Schumm-Draeger PM, Vora J, et al. A review of modern insulin analogue pharmacokinetic and pharmacodynamic profiles in type 2 diabetes: improvements and limitations. Diabetes Obes Metab. 2011;13(8):677–84.PubMedCrossRef
68.
Zurück zum Zitat Gerstein HC, Bosch J, Dagenais GR, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012;367(4):319–28.PubMedCrossRef Gerstein HC, Bosch J, Dagenais GR, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012;367(4):319–28.PubMedCrossRef
69.
Zurück zum Zitat Wang F, Surh J, Kaur M. Insulin degludec as an ultralong-acting basal insulin once a day: a systematic review. Diabetes Metab Syndr Obes. 2012;5:191–204.PubMedCrossRef Wang F, Surh J, Kaur M. Insulin degludec as an ultralong-acting basal insulin once a day: a systematic review. Diabetes Metab Syndr Obes. 2012;5:191–204.PubMedCrossRef
Metadaten
Titel
Insulin Degludec and Insulin Degludec/Insulin Aspart: A Review of Their Use in the Management of Diabetes Mellitus
verfasst von
Gillian M. Keating
Publikationsdatum
01.05.2013
Verlag
Springer International Publishing AG
Erschienen in
Drugs / Ausgabe 6/2013
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-013-0051-1

Weitere Artikel der Ausgabe 6/2013

Drugs 6/2013 Zur Ausgabe