메뉴 건너뛰기




Volumn 16, Issue 3, 2015, Pages 164-176

Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes

Author keywords

Adolescents; Children; Insulin degludec; Type 1 diabetes

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN ASPART; INSULIN DEGLUDEC; INSULIN DETEMIR; ANTIDIABETIC AGENT; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; LONG ACTING INSULIN;

EID: 84926218961     PISSN: 1399543X     EISSN: 13995448     Source Type: Journal    
DOI: 10.1111/pedi.12263     Document Type: Article
Times cited : (67)

References (38)
  • 1
    • 0027370108 scopus 로고
    • The effect of intensive treatment of diabetes on the development and progression of long-term complications of insulin-dependent diabetes mellitus
    • The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications of insulin-dependent diabetes mellitus. N Engl J Med 1993: 329: 979-986.
    • (1993) N Engl J Med , vol.329 , pp. 979-986
  • 2
    • 0028824760 scopus 로고
    • Adverse events and their association with treatment regimens in the Diabetes Control and Complications Trial
    • The Diabetes Control and Complications Trial Research Group. Adverse events and their association with treatment regimens in the Diabetes Control and Complications Trial. Diabetes Care 1995: 18: 1415-1427.
    • (1995) Diabetes Care , vol.18 , pp. 1415-1427
  • 3
    • 0034628425 scopus 로고    scopus 로고
    • Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy
    • The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med 2000: 342: 381-389.
    • (2000) N Engl J Med , vol.342 , pp. 381-389
  • 4
    • 0037093012 scopus 로고    scopus 로고
    • Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus
    • The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA 2002: 287: 2563-2569.
    • (2002) JAMA , vol.287 , pp. 2563-2569
  • 5
    • 29144453326 scopus 로고    scopus 로고
    • Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes
    • The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005: 353: 2643-2653.
    • (2005) N Engl J Med , vol.353 , pp. 2643-2653
  • 7
    • 84906840614 scopus 로고    scopus 로고
    • ISPAD Clinical Practice Consensus Guidelines 2014 Compendium. Assessment and monitoring of glycemic control in children and adolescents with diabetes
    • Rewers M, Pihoker C, Donaghue K, Hanas R, Swift P, Klingensmith GJ. ISPAD Clinical Practice Consensus Guidelines 2014 Compendium. Assessment and monitoring of glycemic control in children and adolescents with diabetes. Pediatr Diabetes 2014: 15 (Suppl. 20): 102-114.
    • (2014) Pediatr Diabetes , vol.15 , pp. 102-114
    • Rewers, M.1    Pihoker, C.2    Donaghue, K.3    Hanas, R.4    Swift, P.5    Klingensmith, G.J.6
  • 8
    • 84903552407 scopus 로고    scopus 로고
    • Type 1 diabetes sourcebook authors. Type 1 diabetes through the life span: a position statement of the American Diabetes Association
    • Chiang JL, Kirkman MS, Laffel LM, Peters AL. Type 1 diabetes sourcebook authors. Type 1 diabetes through the life span: a position statement of the American Diabetes Association. Diabetes Care 2014: 37: 2034-2054.
    • (2014) Diabetes Care , vol.37 , pp. 2034-2054
    • Chiang, J.L.1    Kirkman, M.S.2    Laffel, L.M.3    Peters, A.L.4
  • 9
    • 1842507154 scopus 로고    scopus 로고
    • Neurocognitive correlation of type 1 diabetes mellitus in childhood
    • Desrocher M, Rovet J. Neurocognitive correlation of type 1 diabetes mellitus in childhood. Neuropsychol Dev 2004: 10: 36-52.
    • (2004) Neuropsychol Dev , vol.10 , pp. 36-52
    • Desrocher, M.1    Rovet, J.2
  • 10
    • 70349575972 scopus 로고    scopus 로고
    • Assessment and management of hypoglycemia in children and adolescents with diabetes
    • Clarke W, Jones T, Rewers A, Dunger D, Klingensmith GJ. Assessment and management of hypoglycemia in children and adolescents with diabetes. Pediatr Diabetes 2009: 10 (Suppl. 12): 134-145.
    • (2009) Pediatr Diabetes , vol.10 , pp. 134-145
    • Clarke, W.1    Jones, T.2    Rewers, A.3    Dunger, D.4    Klingensmith, G.J.5
  • 11
    • 84913588693 scopus 로고    scopus 로고
    • Diabetic ketoacidosis in children and adolescents with diabetes
    • ISPAD Clinical Practice Consensus Guidelines 2014 Compendium
    • Wolfsdorf J, ISPAD Clinical Practice Consensus Guidelines 2014 Compendium. Diabetic ketoacidosis in children and adolescents with diabetes. Pediatr Diabetes 2014: 15 (Suppl. 20): 154-179.
    • (2014) Pediatr Diabetes , vol.15 , pp. 154-179
    • Wolfsdorf, J.1
  • 12
    • 0031590552 scopus 로고    scopus 로고
    • Adherence to insulin treatment, glycaemic control, and ketoacidosis in insulin-dependent diabetes mellitus. Diabetes Audit and Research in Tayside Scotland Medicines Monitoring Unit
    • Morris AD, Boyle DI, McMahon AD, Greene SA, MacDonald TM, Newton RW. Adherence to insulin treatment, glycaemic control, and ketoacidosis in insulin-dependent diabetes mellitus. Diabetes Audit and Research in Tayside Scotland Medicines Monitoring Unit. Lancet 1997: 350: 1505-1510.
    • (1997) Lancet , vol.350 , pp. 1505-1510
    • Morris, A.D.1    Boyle, D.I.2    McMahon, A.D.3    Greene, S.A.4    MacDonald, T.M.5    Newton, R.W.6
  • 13
    • 0037093149 scopus 로고    scopus 로고
    • Predictors of acute complications in children with type 1 diabetes
    • Rewers A, Chase HP, Mackenzie T et al. Predictors of acute complications in children with type 1 diabetes. JAMA 2002: 287: 2511-2518.
    • (2002) JAMA , vol.287 , pp. 2511-2518
    • Rewers, A.1    Chase, H.P.2    Mackenzie, T.3
  • 14
    • 85116183939 scopus 로고    scopus 로고
    • ® Summary of product characteristics
    • (available from)
    • ® Summary of product characteristics (available from http://www.medicines.org.uk/emc/medicine/25506)
  • 15
    • 85116183538 scopus 로고    scopus 로고
    • ® Summary of product characteristics
    • (available from)
    • ® Summary of product characteristics (available from http://www.medicines.org.uk/emc/medicine/14584)
  • 16
    • 84859883969 scopus 로고    scopus 로고
    • Insulin degludec has a two-fold longer half-life and a more consistent pharmacokinetic profile than insulin glargine
    • Abstract.
    • Heise T, Hovelmann U, Nosek L, Bottcher S, Granhall C, Hahhr H. Insulin degludec has a two-fold longer half-life and a more consistent pharmacokinetic profile than insulin glargine. Diabetes 2011: 60 (Suppl. 1A): LB11 (Abstract).
    • (2011) Diabetes , vol.60 , pp. LB11
    • Heise, T.1    Hovelmann, U.2    Nosek, L.3    Bottcher, S.4    Granhall, C.5    Hahhr, H.6
  • 17
    • 84864375931 scopus 로고    scopus 로고
    • Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes
    • 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.
    • (2012) Diabetes Obes Metab , vol.14 , pp. 859-864
    • Heise, T.1    Hermanski, L.2    Nosek, L.3    Feldman, A.4    Rasmussen, S.5    Haahr, H.6
  • 18
    • 84920991726 scopus 로고    scopus 로고
    • A review of the pharmacological properties of insulin degludec and their clinical relevance
    • Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet 2014: 53: 787-800.
    • (2014) Clin Pharmacokinet , vol.53 , pp. 787-800
    • Haahr, H.1    Heise, T.2
  • 19
    • 84859896417 scopus 로고    scopus 로고
    • 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
    • Heller S, Buse J, Fisher M et al. 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.
    • (2012) Lancet , vol.379 , pp. 1489-1497
    • Heller, S.1    Buse, J.2    Fisher, M.3
  • 20
    • 84875444482 scopus 로고    scopus 로고
    • 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
    • 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: 858-864.
    • (2013) Diabetes Care , vol.36 , pp. 858-864
    • Meneghini, L.1    Atkin, S.L.2    Gough, S.C.3
  • 21
    • 84874858316 scopus 로고    scopus 로고
    • 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
    • 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: 1154-1162.
    • (2013) J Clin Endocrinol Metab , vol.98 , pp. 1154-1162
    • Mathieu, C.1    Hollander, P.2    Miranda-Palma, B.3
  • 22
    • 73349118174 scopus 로고    scopus 로고
    • Ethical principles for medical research involving human subjects
    • Declaration of Helsinki
    • World Medical Association Inc. Declaration of Helsinki. Ethical principles for medical research involving human subjects. J Indian Med Assoc 2009: 107: 403-405.
    • (2009) J Indian Med Assoc , vol.107 , pp. 403-405
  • 23
    • 0035720060 scopus 로고    scopus 로고
    • Guideline for good clinical practice
    • ICH Harmonised Tripartite Guideline. Guideline for good clinical practice. J Postgrad Med 2001: 47: 199-203.
    • (2001) J Postgrad Med , vol.47 , pp. 199-203
  • 24
    • 0036580827 scopus 로고    scopus 로고
    • Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes
    • Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Råstam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care 2002: 25: 876-882.
    • (2002) Diabetes Care , vol.25 , pp. 876-882
    • Lindholm, A.1    Jensen, L.B.2    Home, P.D.3    Raskin, P.4    Boehm, B.O.5    Råstam, J.6
  • 25
    • 3142534409 scopus 로고    scopus 로고
    • Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
    • Mire-Sluis AR, Barrett YC, Devanarayan V et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 2004: 289: 1-16.
    • (2004) J Immunol Methods , vol.289 , pp. 1-16
    • Mire-Sluis, A.R.1    Barrett, Y.C.2    Devanarayan, V.3
  • 26
    • 84926193360 scopus 로고    scopus 로고
    • Guidance for Industry: diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. Draft Guidance 2008 Rockville, MD: US Department of Health and Human Services
    • Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) [online] (available from). Accessed February 21.
    • Food and Drug Administration. Guidance for Industry: diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. Draft Guidance 2008 Rockville, MD: US Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) [online] (available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071624.pdf). Accessed February 21, 2012.
    • (2012)
  • 27
    • 84864460325 scopus 로고    scopus 로고
    • Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin
    • 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.
    • (2012) Pharm Res , vol.29 , pp. 2104-2114
    • Jonassen, I.1    Havelund, S.2    Hoeg-Jensen, T.3    Steensgaard, D.B.4    Wahlund, P.O.5    Ribel, U.6
  • 28
    • 34948861041 scopus 로고    scopus 로고
    • Refining basal insulin therapy: what have we learned in the age of analogues?
    • 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: 441-454.
    • (2007) Diabetes Metab Res Rev , vol.23 , pp. 441-454
    • DeVries, J.H.1    Nattrass, M.2    Pieber, T.R.3
  • 29
    • 64549093838 scopus 로고    scopus 로고
    • Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT)
    • Le Floch JP, Lévy M, Mosnier-Pudar H et al. Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT). Diabetes Care 2009: 32: 32-37.
    • (2009) Diabetes Care , vol.32 , pp. 32-37
    • Le Floch, J.P.1    Lévy, M.2    Mosnier-Pudar, H.3
  • 30
    • 84893072820 scopus 로고    scopus 로고
    • Insulin degludec's ultra-long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes
    • Biester T, Blaesig S, Remus K et al. Insulin degludec's ultra-long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes. Pediatr Diabetes 2014: 15: 27-33.
    • (2014) Pediatr Diabetes , vol.15 , pp. 27-33
    • Biester, T.1    Blaesig, S.2    Remus, K.3
  • 31
    • 18144388647 scopus 로고    scopus 로고
    • Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia
    • American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005: 28: 1245-1249.
    • (2005) Diabetes Care , vol.28 , pp. 1245-1249
  • 32
    • 84859921058 scopus 로고    scopus 로고
    • Insulin degludec, an ultralong 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
    • Garber AJ, King AB, Del Prato S et al. Insulin degludec, an ultralong 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.
    • (2012) Lancet , vol.379 , pp. 1498-1507
    • Garber, A.J.1    King, A.B.2    Del Prato, S.3
  • 33
    • 84885920592 scopus 로고    scopus 로고
    • Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN Basal-Bolus Type 1): 2-year results of a randomized clinical trial
    • Bode B, Buse JB, Fisher M et al. Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN Basal-Bolus Type 1): 2-year results of a randomized clinical trial. Diabet Med 2013: 30: 1293-1297.
    • (2013) Diabet Med , vol.30 , pp. 1293-1297
    • Bode, B.1    Buse, J.B.2    Fisher, M.3
  • 34
    • 84907369748 scopus 로고    scopus 로고
    • Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, open-label, treat-to-target non-inferiority trial
    • Davies M, Gross JL, Ono Y et al. Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, open-label, treat-to-target non-inferiority trial. Diabetes Obes Metab 2014: 16: 922-930.
    • (2014) Diabetes Obes Metab , vol.16 , pp. 922-930
    • Davies, M.1    Gross, J.L.2    Ono, Y.3
  • 36
    • 33749202971 scopus 로고    scopus 로고
    • Hypoglycaemia and cognitive function in diabetes
    • Frier BM. Hypoglycaemia and cognitive function in diabetes. Int J Clin Pract Suppl 2001: 123: 30-37.
    • (2001) Int J Clin Pract Suppl , vol.123 , pp. 30-37
    • Frier, B.M.1
  • 37
    • 84877709171 scopus 로고    scopus 로고
    • Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and The Endocrine Society
    • Seaquist ER, Anderson J, Childs B et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and The Endocrine Society. J Clin Endocrinol Metab 2013: 98: 1845-1859.
    • (2013) J Clin Endocrinol Metab , vol.98 , pp. 1845-1859
    • Seaquist, E.R.1    Anderson, J.2    Childs, B.3
  • 38
    • 85116183844 scopus 로고    scopus 로고
    • ® Summary of product characteristics
    • available from
    • ® Summary of product characteristics (available from http://www.medicines.org.uk/emc/medicine/27363/SPC/Tresiba+200+units+mL+Pre-filled+Pen+(FlexTouch)/)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.