#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Clinical data on the use of insulin glargine 300 U/ml in adult and paediatric populations with type 1 diabetes and their meta-analysis


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 2020; 20(40): 78-83
Category:

Overview

People with type 1 diabetes (T1D) are dependent on regular application of insulin from the time of the diagnosis and for the rest of their lives. Good metabolic compensation reduces the risk of long-term diabetic complications. These efforts are hampered, however, by the proportionally increased risk of hypoglycaemia and severe hypoglycaemia. The right choice of insulin preparation, timing and the mode of its application are therefore key factors in the management of this condition. In this work the author presents clinical trials examining the use of second-generation basal insulin analog glargine 300 U/ml in adult and pediatric populations of people with T1D and their meta-analysis. These data confirm efficacy and safety of glargine 300 U/ml in this population with a concomitant decreased risk of severe hypoglycaemia, in particular in the titration period (compared with insulin glargine 100 U/ml).

Keywords:

basal insulin – glargine 300 U/ml – glargine 100 U/ml – hypoglycaemia – insulin degludec – nocturnal hypoglycaemia – type 1 diabetes (T1D)


Sources
  1. Melmed S, Polonsky KS, Larsen PR et al. Williams Textbook of Endocrinology. 12th ed. Elsevier Saunders 2011. ISBN 978–1437703245.
  2. Nathan DM, Genuth S, 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>.
  3. Nathan DM, Bayless M, Cleary P et al. Diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: advances and contributions. Diabetes 2013; 62(12): 3976–3986. Dostupné z DOI: <http://dx.doi.org/10.2337/db13–1093>.
  4. Banting FG, Best CH, Collip JB et al. Pancreatic Extracts in the Treatment of Diabetes Mellitus. Can Med Assoc J 1922; 12(3): 141–146.
  5. Novodvorsky P, Heller SR. Hypoglycaemia in Diabetes. Medicine 2019; 47(1): P52-P58. Dostupné z DOI: <https://doi.org/10.1016/j.mpmed.2018.10.005>.
  6. Iqbal A, Novodvorsky P, Heller SR. Recent Updates on Type 1 Diabetes Mellitus Management for Clinicians. Diabetes Metab J 2018; 42(1): 3–18. Dostupné z DOI: <http://dx.doi.org/10.4093/dmj.2018.42.1.3>.
  7. Heise T, Mathieu C. Impact of the mode of protraction of basal insulin therapies on their pharmacokinetic and pharmacodynamic properties and resulting clinical outcomes. Diabetes Obes Metab 2017; 19(1): 3–12. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12782>.
  8. 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. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12032>.
  9. 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. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12485>.
  10. International Hypoglycaemia Study Group. Glucose Concentrations of Less Than 3.0 mmol/L (54 mg/dL) should be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2017; 40(1): 155–157. Dostupné z DOI: <http://dx.doi.org/10.2337/dc16–2215>.
  11. Home PD, Bergenstal RM, Bolli GB et al. New Insulin Glargine 300 Units/mL versus Glargine 100 Units/mL in People with Type 1 Diabetes: A Randomized, Phase 3a, Open-Label Clinical Trial (EDITION 4). Diabetes Care 2015; 38(12): 2217–2225. Dostupné z DOI: <http://dx.doi.org/10.2337/dc15–0249>.
  12. Matsuhisa M, Koyama M, Cheng X et al. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab 2016; 18(4): 375–383. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12619>.
  13. Danne T, Tamborlane WV, Malievsky OA et al. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) with Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care 2020; 43(7): 1512–1519. Dostupné z DOI: <http://dx.doi.org/10.2337/dc19–1926>.
  14. Danne T, Matsuhisa M, Sussebach C et al. Lower Risk for Severe Hypoglycaemia with Insulin Glargine 300 U/mL vs Glargine 100 U/mL in Participants with Type 1 Diabetes: a Meta-Analysis of 6-Month Phase 3 Clinical Trials. Diabetes Obes Metab 2020. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.14109>.
  15. 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>.
Labels
Diabetology Obesitology

Article was published in

Diabetes a obezita

Issue 40

2020 Issue 40

Most read in this issue
Login
Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account

#ADS_BOTTOM_SCRIPTS#