Insulin glargine 300 U/mL and insulin degludec: A review of the current evidence comparing these two second-generation basal insulin analogues.

insulin degludec insulin glargine second-generation basal insulin type 2 diabetes

Journal

Diabetes/metabolism research and reviews
ISSN: 1520-7560
Titre abrégé: Diabetes Metab Res Rev
Pays: England
ID NLM: 100883450

Informations de publication

Date de publication:
Oct 2020
Historique:
revised: 20 12 2019
received: 31 07 2019
accepted: 12 04 2020
medline: 22 4 2020
pubmed: 22 4 2020
entrez: 22 4 2020
Statut: ppublish

Résumé

For most people with type 2 diabetes (T2D), treatment intensification with the addition of basal insulin therapy is required to maintain glycaemic control. However, this often does not happen in real-life practice promoting the development of long-term diabetes-related complications. The second-generation basal insulin analogues glargine 300 U/mL (Gla-300) and degludec (IDeg) provide pharmacokinetic and pharmacodynamic improvements that may allow them to be more effective in appropriately managing diabetes compared with first-generation basal insulin analogues. Both Gla-300 and IDeg have been extensively studied vs the first-generation basal insulin glargine 100 U/mL, demonstrating comparable efficacy in terms of glycaemic control, and a lower risk of hypoglycaemia. The BRIGHT randomized controlled trial is the first direct comparison of the efficacy and safety profiles of Gla-300 and IDeg in patients with T2D. Moreover, real-world data have been used to assess the effectiveness of these basal insulins during routine clinical practice. Further research is required to determine if the properties of Gla-300 and IDeg may lead to improvements in healthcare-related costs and the quality of life of patients, which are important factors for informing clinical decisions.

Identifiants

pubmed: 32315508
doi: 10.1002/dmrr.3329
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

e3329

Subventions

Organisme : Sanofi

Informations de copyright

© 2020 John Wiley & Sons Ltd.

Références

American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: standards of medical Care in diabetes-2018. Diabetes Care. 2018;41(Suppl 1):S73-S85.
American Diabetes Association. 6. Glycemic targets: standards of medical Care in diabetes-2018. Diabetes Care. 2018;41(Suppl 1):S55-S64.
Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321(7258):405-412.
Khunti K, Wolden ML, Thorsted BL, Andersen M, Davies MJ. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care. 2013;36(11):3411-3417.
Mauricio D, Meneghini L, Seufert J, et al. Glycaemic control and hypoglycaemia burden in patients with type 2 diabetes initiating basal insulin in Europe and the USA. Diabetes Obes Metab. 2017;19(8):1155-1164.
Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care. 2005;28(10):2543-2545.
Russell-Jones D, Pouwer F, Khunti K. Identification of barriers to insulin therapy and approaches to overcoming them. Diabetes Obes Metab. 2018;20(3):488-496.
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(5):682-689.
Heise T, Hovelmann U, Nosek L, Hermanski L, Bottcher SG, Haahr H. Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol. 2015;11(8):1193-1201.
Becker RH, Dahmen R, Bergmann K, Lehmann A, Jax T, Heise T. New insulin glargine 300 Units · mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units · mL-1. Diabetes Care 2015;38(4):637-643
Bergenstal RM, Bailey TS, Rodbard D, et al. Comparison of insulin glargine 300 units/mL and 100 units/mL in adults with type 1 diabetes: continuous glucose monitoring profiles and variability using morning or evening injections. Diabetes Care. 2017;40(4):554-560.
Riddle MC, Bolli GB, Home PD, et al. Efficacy and safety of flexible versus fixed dosing intervals of insulin glargine 300 U/mL in people with type 2 diabetes. Diabetes Technol Ther. 2016;18(4):252-257.
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(9):859-864.
Bailey TS, Pettus J, Roussel R, et al. Morning administration of 0.4 U/kg/day insulin glargine 300 U/mL provides less fluctuating 24-hour pharmacodynamics and more even pharmacokinetic profiles compared with insulin degludec 100U/mL in type 1 diabetes. Diabetes Metab. 2018;44(1):15-21.
Heise T, Norskov M, Nosek L, Kaplan K, Famulla S, Haahr HL. Insulin degludec: lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab. 2017;19(7):1032-1039.
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):1498-1507.
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):2464-2471.
Gough SC, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. Low-volume insulin degludec 200 units/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(9):2536-2542.
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(4):858-864.
Onishi Y, Iwamoto Y, Yoo SJ, Clauson P, Tamer SC, Park S. Insulin degludec compared with insulin glargine in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, Pan-Asian, treat-to-target trial. J Diabetes Investig. 2013;4(6):605-612.
Riddle MC, Bolli GB, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014;37(10):2755-2762.
Yki-Jarvinen H, Bergenstal RM, Bolli GB, et al. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015;17(12):1142-1149.
Bolli GB, Riddle MC, Bergenstal RM, et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015;17(4):386-394.
Terauchi Y, Koyama M, Cheng X, et al. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2). Diabetes Obes Metab. 2016;18(4):366-374.
Ritzel R, Roussel R, Bolli GB, et al. Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes. Diabetes Obes Metab. 2015;17(9):859-867.
Rodbard HW, Gough S, Lane W, Korsholm L, Bretler DM, Handelsman Y. Reduced risk of hypoglycemia with insulin degludec versus insulin glargine in patients with type 2 diabetes requiring high doses of basal insulin: a meta-analysis of 5 randomized begin trials. Endocr Pract. 2014;20(4):285-292.
Ratner RE, Gough SC, Mathieu C, 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(2):175-184.
Roussel R, Ritzel R, Boelle-Le Corfec E, Balkau B, Rosenstock J. Clinical perspectives from the BEGIN and EDITION programmes: trial-level meta-analyses outcomes with either degludec or glargine 300 U/mL vs glargine 100 U/mL in T2DM. Diabetes Metab. 2018;44:402-409.
Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med. 2017;377(8):723-732.
Rosenstock J, Cheng A, Ritzel R, et al. More similarities than differences testing insulin glargine 300 U/mL versus insulin degludec 100 U/mL in insulin-naïve type 2 diabetes: The randomized head-to-head BRIGHT trial. Diabetes Care. 2018;41:2147-2154.
Ritzel R, Cheng A, Bosnyak Z, et al. Similar variability of fasting and 24-hr self-measured plasma glucose withGla-300 vs IDeg-100 in insulin-naive adults with type 2 diabetes: the randomised BRIGHT trial [Abstract 893]. In: 54(th) EASD Annual Meeting of the European Association for the Study of Diabetes: Berlin, Germany, 1-5 October 2018. Diabetologia. 2018;61(Suppl 1):1-620.
Cheng A, Harris S, Giorgino F, et al. Similar glycaemic control and less hypoglycaemia during active titration after insulin initiation with Gla-300 vs IDeg-100: a subanalysis of the BRIGHT study. Diabetes Obes Metab. 2019;22:346-354.
Philis-Tsimikas A, Klonoff DC, Bajaj HS, et al. Reduced risk of hypoglycaemia and lower HbA1c with degludec compared to glargine U300 in insulin-treated patients with type 2 diabetes [Abstract 90]. In: 55th EASD Annual Meeting of the European Association for the Study of Diabetes, Barcelona, Spain, 16 - 20 September 2019. Diabetologia. 2019;62(Suppl 1):1-600.
Sullivan SD, Bailey TS, Roussel R, et al. Clinical outcomes in real-world patients with type 2 diabetes switching from first- to second-generation basal insulin analogues: comparative effectiveness of insulin glargine 300 units/mL and insulin degludec in the DELIVER D+ cohort study. Diabetes Obes Metab. 2018;20:2148-2158.
Pettus J, Roussel R, Liz Zhou F, et al. Rates of hypoglycemia predicted in patients with type 2 diabetes on insulin glargine 300 U/ml versus first- and second-generation basal insulin analogs: the real-world LIGHTNING study. Diabetes Ther. 2019;10(2):617-633.
Tibaldi J, Haldrup S, Sandberg V, Wolden ML, Rodbard HW. Clinical outcome assessment of the effectiveness of insulin degludec in real-life medical practice (CONFIRM): a comparative effectiveness study of degludec and insulin glargine 300 units/mL in insulin-naïve patients with type 2 diabetes. Diabetes. 2018;67(S1):A101-A568.
Sullivan SD, Nicholls CJ, Gupta RA, et al. Comparable glycaemic control and hypoglycaemia in adults with type 2 diabetes after initiating insulin glargine 300 units/mL or insulin degludec: The DELIVER Naïve D real-world study. Diabetes Obes Metab. 2019;21(9):2123-2132.
Zhou FL, Ye F, Berhanu P, et al. Real-world evidence concerning clinical and economic outcomes of switching to insulin glargine 300 units/mL vs other basal insulins in patients with type 2 diabetes using basal insulin. Diabetes Obes Metab. 2018;20(5):1293-1297.
Ericsson A, Pollock RF, Hunt B, Valentine WJ. Evaluation of the cost-utility of insulin degludec vs insulin glargine in Sweden. J Med Econ. 2013;16(12):1442-1452.
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 UKhealth care cost perspective. Diabetes Obes Metab. 2014;16(4):366-375.
Lane WS, Weatherall J, Gundgaard J, Pollock RF. Insulin degludec versus insulin glargine U100 for patients with type 1 or type 2 diabetes in the US: a budget impact analysis with rebate tables. J Med Econ. 2018;21(2):144-151.
Dalal M, Feliciano J, Kelton K, Klein T, Murphy D. Translating trial-based efficacy and safety into cost comparison for new insulin glargine 300 U/mL (Gla-300). J Manag Care Spec Pharm. 2016;22(4a):S46.
Karamat MA, Dar S, Bellary S, Tahrani AA. Clinical and cost implications of insulin degludec in patients with type 1 diabetes and problematic hypoglycemia: a quality improvement project. Diabetes Ther. 2018;9(2):839-849.
Mezquita-Raya P, Darba J, Ascanio M, Ramirez de Arellano A. Cost-effectiveness analysis of insulin degludec compared with insulin glargine u100 for the management of type 1 and type 2 diabetes mellitus - from the Spanish National Health System perspective. Expert Rev Pharmacoecon Outcomes Res. 2017;17(6):587-595.
Pollock RF, Tikkanen CK. A short-term cost-utility analysis of insulin degludec versus insulin glargine U100 in patients with type 1 or type 2 diabetes in Denmark. J Med Econ. 2017;20(3):213-220.
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(1):56-68.
Evans M, Chubb B, Gundgaard J. Cost-effectiveness of insulin Degludec versus insulin glargine in adults with type 1 and type 2 diabetes mellitus. Diabetes Ther. 2017;8(2):275-291.
Murphy D, Yu X, Fournier M, et al. Cost-effectiveness of insulin glargine 300 units/ml (GLA-300) vs insulin degludec 100 units/ml (IDEG) IN T2D. Diabetes. 2017;66(Supplement 1):A354.
Weatherall J, Bloudek L, Buchs S. Budget impact of treating commercially insured type 1 and type 2 diabetes patients in the United States with insulin degludec compared to insulin glargine. Curr Med Res Opin. 2017;33(2):231-238.
Blonde L, Zhou FL, Bosnyak Z, et al. Real-world evidence demonstrates comparable clinical outcomes of switching from insulin glargine 100 u/ml (GLA-100) to insulin glargine 300 u/ml (GLA-300) vs insulin degludec (IDEG) in patients with type 2 diabetes (T2D). Endocr Pract. 2018;24(1):1A-46A.
Polonsky WH, Henry RR. Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors. Patient Prefer Adherence. 2016;10:1299-1307.
Leiter LA, Yale J-F, Chiasson J-L, Harris S, Kleinstiver P, Sauriol L. Assessment of the impact of fear of hypoglycemic episodes on glycemic and hypoglycemia management. Can J Diabetes. 2005;29(3):00-00.

Auteurs

Alice Cheng (A)

Division of Endocrinology and Metabolism, University of Toronto, Toronto, Ontario, Canada.

Timothy S Bailey (TS)

AMCR Institute, Escondido, California, USA.

Didac Mauricio (D)

Department of Endocrinology & Nutrition, CIBER of Diabetes and Associated Metabolic Diseases, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

Ronan Roussel (R)

Diabetology Endocrinology Nutrition, Hôpital Bichat, Assistance Publique Hôpitaux de Paris, Paris, France.
INSERM, U-1138, Centre de Recherche des Cordeliers, Paris, France.
UFR de Médecine, Paris University, Paris, France.

Classifications MeSH