News in the field of 2nd generation of basal insulin analogs in type 1 diabetes and data from continuous glucose monitoring

Czech version

Authors: Peter Novodvorský ^1,2
Authors‘ workplace: metabolické centrum s. r. o., Trenčín ¹; Department of Oncology & Metabolism, Medical School, University of Sheffield, United Kingdom ²
Published in: Diab Obez 2021; 21(41): 23-28
Category:

Overview

Therapy with insulin represents the mainstay of type 1 diabetes (T1D) management. Insulin is mostly administered via multiple daily insulin/injections (MDI) regimen or via continuous subcutaneous insulin infusion (CSII), the so-called insulin pump. The 2^nd generation of basal insulin analogs – insulin glargin 300 U/ml and insulin degludec – are the newest basal insulins on the market. Their efficacy and safety in the management of T1D has been proven in number of randomized controlled trials (RCT) as well as by the real-world evidence (RWE) studies. Yet, there is paucity of robust data examining their efficacy and safety assessed by the continuous glucose monitoring (CGM) metrics. This paper looks at the current available evidence on the efficacy and safety of the 2^nd generation of basal insulin analogs assessed by the CGM technology and concludes with the design of the already ongoing ‘InRange‘ RCT which compares the efficacy and safety of insulin glargin 300 U/ml and insulin degludec via CGM metrics in an adult population with DM1T.

Keywords:

basal insulin – continuous glucose monitoring (CGM) – hypoglycaemia – insulin degludec – insulin Glargine 300 U/ml – nocturnal hypoglycaemia – real-world evidence (RWE) study – type 1 diabetes (T1D)

Sources

[American Diabetes Association]. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care 2021; 44(Suppl 1): S73-S84. Dostupné z DOI: <http://dx.doi.org/10.2337/dc21-S006>.
Pettus J, Santos Cavaiola T, Tamborlane WV et al. The past, present, and future of basal insulins. Diabetes Metab Res Rev 2016; 32(6): 478–496. Dostupné z DOI: <http://dx.doi.org/10.1002/dmrr.2763>.
Miller KM, Foster NC, Beck RW et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care 2015; 38(6): 971–978. Dostupné z DOI: <http://dx.doi.org/10.2337/dc15–0078>.
Nathan DM, Genuth S, J Lachin J et al. [Diabetes Control and Complications Trial Research Group]. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329(14): 977–986. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJM199309303291401>.
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. Dostupné z DOI: <http://dx.doi.org/10.1136/bmj.321.7258.405>.
Danne T, Nimri R, Battelino T et al. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care 2017; 40(12): 1631–1640. Dostupné z DOI: <http://dx.doi.org/10.2337/dc17–1600>.
Battelino T, Danne T, Bergenstal RM et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care 2019; 42(8): 1593–1603. Dostupné z DOI: <http://dx.doi.org/10.2337/dci19–0028>.
Beck RW, Bergenstal RM, Cheng P et al. The Relationships Between Time in Range, Hyperglycemia Metrics, and HbA1c. J Diabetes Sci Technol 2019; 13(4): 614–626. Dostupné z DOI: <http://dx.doi.org/10.1177/1932296818822496>.
Vigersky RA, McMahon C. The Relationship of Hemoglobin A1C to Time-in-Range in Patients with Diabetes. Diabetes Technol Ther 2019; 21(2): 81–85. Dostupné z DOI: <http://dx.doi.org/10.1089/dia.2018.0310>.
Battelino T, Edelman SV, Nishimura R et al. Comparison of Second-Generation Basal Insulin Analogs: A Review of the Evidence from Continuous Glucose Monitoring. Diabetes Technol Ther 2021; 23(1): 20–30. Dostupné z DOI: <http://dx.doi.org/10.1089/dia.2020.0180>.
Battelino T, Bosnyak Z, Danne T et al. InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design. Diabetes Ther 2020; 11(4): 1017–1027. Dostupné z DOI: <http://dx.doi.org/10.1007/s13300–020–00781–6>.
Battelino T, Bosnyak Z, Danne T et al. Correction to: InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design. Diabetes Ther 2020; 11(8): 1907–1908. Dostupné z DOI: <http://dx.doi.org/10.1007/s13300–020–00853–7>.
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. Dostupné z DOI: <http://dx.doi.org/10.2337/dc16–0684>.
Okajima F, Nakamura Y, Yamaguchi Y et al. Basal-Bolus Insulin Therapy with Gla-300 During Hospitalization Reduces Nocturnal Hypoglycemia in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Study. Diabetes Ther 2018; 9(3): 1049–1059. Dostupné z DOI: <http://dx.doi.org/10.1007/s13300–018–0419-z>.
Jinnouchi H, Koyama M, Amano A et al. Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300 U mL(-1) and Glargine 100 U mL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study. Diabetes Ther 2015; 6(2): 143–152. Dostupné z DOI: <http://dx.doi.org/10.1007/s13300–015–0115–1>.
Henao-Carrillo DC, Munoz OM, Gomez AM et al. Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes. J Clin Transl Endocrinol 2018; 12: 8–12. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jcte.2018.03.003>.
Yamamoto C, Miyoshi H, Fujiwara Y et al. Degludec is superior to glargine in terms of daily glycemic variability in people with type 1 diabetes mellitus. Endocr J 2016; 63(1): 53–60. Dostupné z DOI: <http://dx.doi.org/10.1507/endocrj.EJ15–0438>.
Galasso S, Facchinetti A, Bonora BM et al. Switching from twice-daily glargine or detemir to once-daily degludec improves glucose control in type 1 diabetes. An observational study. Nutr Metab Cardiovasc Dis 2016; 26(12):1112–1119. Dostupné z DOI: <http://dx.doi.org/10.1016/j.numecd.2016.08.002.
Kawaguchi Y, Sawa J, Sakuma N et al. Efficacy and safety of insulin glargine 300 U/mL vs insulin degludec in patients with type 2 diabetes: A randomized, open-label, cross-over study using continuous glucose monitoring profiles. J Diabetes Investig 2019; 10(2): 343–351. Dostupné z DOI: <http://dx.doi.org/10.1111/jdi.12884>.
Yamabe M, Kuroda M, Hirosawa Y et al. Comparison of insulin glargine 300 U/mL and insulin degludec using flash glucose monitoring: A randomized cross-over study. J Diabetes Investig 2019; 10(2): 352–357. Dostupné z DOI: <http://dx.doi.org/10.1111/jdi.12894>.
Conget I, Delgado E, Mangas MÁ et al. Effectiveness and safety of Gla-300 vs IDeg 100 evaluated with continuous glucose monitoring profile in adults with type 1 diabetes in routine clinical practice in Spain: OneCARE study. Abstr 670. EASD Virtual Meeting Vienna 2020.
Gokhale M, Sturmer T, Buse JB. Real-world evidence: the devil is in the detail. Diabetologia 2020; 63(9): 1694–705. Dostupné z DOI: <http://dx.doi.org/10.1007/s00125–020–05217–1>.
Kim HS, Lee S, Kim JH. Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records. J Korean Med Sci 2018; 33(34): e213. Dostupné z DOI: <http://dx.doi.org/10.3346/jkms.2018.33.e213>.