Long-acting insulin analogue in the treatment of type 2 diabetes mellitus: emphasis on proven efficacy and safety
https://doi.org/10.21518/2079-701X-2021-12-246-255
Abstract
In time, prescription of insulin therapy (IT) becomes inevitable for many patients with type 2 diabetes mellitus (DM) to achieve and maintain the target hypoglycemic range.
According to the current guidelines, the addition of basal insulin to glucose-lowering therapy in patients with insufficient control of type 2 diabetes, gradual titration of its dose in accordance with a fasting blood glucose level is an effective and safe method for initiating IT. The properties of modern long-acting insulin analogues are considered. Glargine 300 U/ml is a modern analogue of long-acting insulin that is intended to be used once a day. The glargine molecule forms the basis of the drug. Increasing the concentration of glargine per volume unit and formation of a smaller subcutaneous depot led to a change in the pharmacokinetic properties of the drug. Glargine 300 IU/ml provides a more stable, long-term, predictable action with low glycemic variability as compared with glargine 100 IU/ml, which reduces the risk of hypoglycemia. The sugar-reducing efficacy and safety of insulin glargine 300 U/ml as evidenced by the findings of the international clinical phase III EDITION studies are discussed. Insulin glargine 300 U/ml showed a similar decrease in HbA1c levels compared to insulin glargine 100 U/ml with an improved safety profile (lower risk of developing episodes of confirmed or severe hypoglycemia at all times of the day, including the nighttime) and a less pronounced effect on the body weight of patients with type 2 diabetes. The efficacy and safety of the use of glargine 300 U/ml has been confirmed in type 2 diabetes patients with chronic kidney disease and the elderly. In the BRIGHT study, glargine 300 U/ml showed comparable glycemic control when it is being compared.
About the Authors
E. V. Biryukova
Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation
Russian Federation
Dr. Sci. (Med.), Professor of the Department of Endocrinology and Diabetology,
20, Bldg. 1, Delegatskaya St., Moscow, 127473
M. V. Shinkin
Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation
Russian Federation
Researcher, Department of Endocrine and Metabolic Disorders, Endocrinologist, Department of Diagnostics and General Therapy,
20, Bldg. 1, Delegatskaya St., Moscow, 127473
O. M. Mikheeva
Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation
Russian Federation
Dr. Sci. (Med.), Professor, Head of the Department of Diagnostics and General Therapy,
20, Bldg. 1, Delegatskaya St., Moscow, 127473
References
1. Chen L., Magliano D.J., Zimmet P.Z. The Worldwide Epidemiology of Type 2 Diabetes Mellitus – Present and Future Perspectives. Nat Rev Endocrinol. 2011;8(4):228–236. https://doi.org/10.1038/nrendo.2011.183.
2. Hanefeld M., Monnier L., Schnell O., Owens D. Early Treatment with Basal Insulin Glargine in People with Type 2 Diabetes: Lessons from ORIGIn and Other Cardiovascular Trials. Diabetes Ther. 2016;7(2):187–201. https://doi.org/10.1007/s13300-016-0153-3.
3. Wajchenberg BL. Beta-Cell Failure in Diabetes and Preservation by Clinical Treatment. Endocr Rev. 2007;28(2):187–218. https://doi.org/10.1210/10.1210/er.2006-0038.
4. Bagust A., Beale S. Deteriorating Beta-Cell Function in Type 2 Diabetes: A Long-Term Model. QJM. 2003;96(4):281–288. https://doi.org/10.1093/qjmed/hcg040.
5. Heine R.J., Diamant M., Mbanya J.C., Nathan D.M. Management of Hyperglycaemia in Type 2 Diabetes: the End of Recurrent Failure? BMJ. 2006;333(7580):1200–1204. https://doi.org/10.1136/bmj.39022.462546.80.
6. Hanefeld M., Fleischmann H., Siegmund T., Seufert J. Rationale for Timely Insulin Therapy in Type 2 Diabetes within the Framework of Individualised Treatment: 2020 Update. Diabetes Ther. 2020;11(8):1645–1666. https://doi.org/10.1007/s13300-020-00855-5.
7. Dedov I.I., Shestakova M.V., Mayorov A.Yu. (eds.). Algorithms for Specialized Medical Care for Patients with Diabetes Mellitus. 9th ed. Sakharnyy diabet = Diabetes Mellitus. 2019;22(1S1):1–144. (In Russ.) https://doi.org/10.14341/DM221S1.
8. Introduction: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S1–S2. https://doi.org/10.2337/dc20-Sint.
9. Fonseca V., Gill J., Zhou R., Leahy J. An Analysis of Early Insulin Glargine Added to Metformin with or without Sulfonylurea: Impact on Glycaemic Control and Hypoglycaemia. Diabetes Obes Metab. 2011;13(9):814–822. https://doi.org/10.1111/j.1463-1326.2011.01412.x.
10. Seufert J., Fritsche A., Pscherer S., Anderten H., Borck A., Pegelow K. et al. Titration and Optimization Trial for the Initiation of Insulin Glargine 100 U/mL in Patients with Inadequately Controlled Type 2 Diabetes on Oral Antidiabetic Drugs. Diabetes Obes Metab. 2019;21(2):439–443. https://doi.org/10.1111/dom.13535.
11. Blonde L., Aschner P., Bailey C., Ji L., Leiter L.A., Matthaei S. Gaps and Barriers in the Control of Blood Glucose in People with Type 2 Diabetes. Diab Vasc Dis Res. 2017;14(3):172–183. https://doi.org/10.1177/1479164116679775.
12. Karam S.L., Dendy J., Polu S., Blonde L. Overview of Therapeutic Inertia in Diabetes: Prevalence, Causes, and Consequences. Diabetes Spectr. 2020;33(1):8–15. https://doi.org/10.2337/ds19-0029.
13. Khan H., Lasker S.S., Chowdhury T.A. Exploring Reasons for Very Poor Glycaemic Control in Patients with Type 2 Diabetes. Prim Care Diabetes. 2011;5(4):251–255. https://doi.org/10.1016/j.pcd.2011.07.001.
14. Mauricio D., Meneghini L., Seufert J., Liao L., Wang H., Tong L. 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. https://doi.org/10.1111/dom.12927.
15. Khunti K., Millar-Jones D. Clinical Inertia to Insulin Initiation and Intensification in the UK: A Focused Literature Review. Prim Care Diabetes. 2017;11(1):3–12. https://doi.org/10.1016/j.pcd.2016.09.003.
16. Lovre D., Fonseca V. Benefits of Timely Basal Insulin Control in Patients with Type 2 Diabetes. J Diabetes Complications. 2015;29(2):295–301. https://doi.org/10.1016/j.jdiacomp.2014.11.018.
17. Khunti K., Wolden M.L., Thorsted B.L., Andersen M., Davies M.J. 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. https://doi.org/10.2337/dc13-0331.
18. Paul S.K., Klein K., Thorsted B.L., Wolden M.L., Khunti K. Delay in Treatment Intensification Increases the Risks of Cardiovascular Events in Patients with Type 2 Diabetes. Cardiovasc Diabetol. 2015;14:100. https://doi.org/10.1186/s12933-015-0260-x.
19. Owens D.R., Matfin G., Monnier L. Basal Insulin Analogues in the Management of Diabetes Mellitus: What Progress Have We Made? Diabetes Metab Res Rev. 2014;30(2):104–119. https://doi.org/10.1002/dmrr.2469.
20. Brown A., Guess N., Dornhorst A., Taheri S., Frost G. Insulin-Associated Weight Gain in Obese Type 2 Diabetes Mellitus Patients: What Can Be Done? Diabetes Obes Metab. 2017;19(12):1655–1668. https://doi.org/10.1111/dom.13009.
21. Zhou Z., Sun B., Huang S., Zhu C., Bian M. Glycemic Variability: Adverse Clinical Outcomes and How to Improve It? Cardiovasc Diabetol. 2020;19(1):102. https://doi.org/10.1186/s12933-020-01085-6.
22. Vora J., Heise T. Variability of Glucose-Lowering Effect as a Limiting Factor in Optimizing Basal Insulin Therapy: A Review. Diabetes Obes Metab. 2013;15(8):701–712. https://doi.org/10.1111/dom.12087.
23. Umpierrez G.E., Kovatchev B.P. Glycemic Variability: How to Measure and Its Clinical Implication for Type 2 Diabetes. Am J Med Sci. 2018;356(6):518–527. https://doi.org/10.1016/j.amjms.2018.09.010.
24. Tibaldi J.M. Evolution of Insulin Development: Focus on Key Parameters. Adv Ther. 2012;29(7):590–619. https://doi.org/10.1007/s12325-012-0034-8.
25. Pettus J., Santos Cavaiola T., Tamborlane W.V., Edelman S. The Past, Present, and Future of Basal Insulins. Diabetes Metab Res Rev. 2016;32(6):478–496. https://doi.org/10.1002/dmrr.2763.
26. Dailey G., Lavernia F. A Review of the Safety and Efficacy Data for Insulin Glargine 300 units/ml, a New Formulation of Insulin Glargine. Diabetes Obes Metab. 2015;17(12):1107–1114. https://doi.org/10.1111/dom.12531.
27. Sutton G., Minguet J., Ferrero C., Bramlage P. U300, A Novel Long-Acting Insulin Formulation. Expert Opin Biol Ther. 2014;14(12):1849–1860. https://doi.org/10.1517/14712598.2014.970633.
28. Riddle M.C., Bolli G.B., Ziemen M., Muehlen-Bartmer I., Bizet F., Home P.D. 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. https://doi.org/10.2337/dc14-0991.
29. Ghosh S., Ghosh R. Glargine-300: An Updated Literature Review on Randomized Controlled Trials and Real-World Studies. World J Diabetes. 2020;11(4):100–114. https://doi.org/10.4239/wjd.v11.i4.100.
30. Yki-Järvinen H., Bergenstal R.M., Bolli G.B., Ziemen M., Wardecki M., MuehlenBartmer I. 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. https://doi.org/10.1111/dom.12532.
31. Bolli G.B., Riddle M.C., Bergenstal R.M., Ziemen M., Sestakauskas K., Goyeau H., Home P.D. New Insulin Glargine 300 U/ml Compared with Glargine 100 U/ml in Insulin-Naïve People with Type 2 Diabetes on Oral Glucose-Lowering Drugs: A Randomized Controlled Trial (EDITION 3). Diabetes Obes Metab. 2015;17(4):386–394. https://doi.org/10.1111/dom.12438.
32. Ritzel R., Roussel R., Bolli G.B., Vinet L., Brulle-Wohlhueter C., Glezer S., YkiJärvinen H. 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. https://doi.org/10.1111/dom.12485.
33. Rosenstock J., Cheng A., Ritzel R., Bosnyak Z., Devisme C., Cali A.M.G. et al. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. Diabetes Care. 2018;41(10):2147–2154. https://doi.org/10.2337/dc18-0559.
34. Kulozik F., Hasslacher C. Insulin Requirements in Patients with Diabetes and Declining Kidney Function: Differences between Insulin Analogues and Human Insulin? Ther Adv Endocrinol Metab. 2013;4(4):113–121. https://doi.org/10.1177/2042018813501188.
35. Haluzik M., Philis‐Tsimikas A., Bosnyak Z., Muller‐Wieland D., Lauand F., Melas‐Melt L. et al. Differences in HbA1c-Lowering Effect and Hypoglycemia Risk between GLA-300 and IDeg According to Renal Function in the BRIGHT Trial. Diabetes. 2019;68(Suppl 1):146-OR. https://doi.org/10.2337/db19-146-OR.
36. Haluzík M., Cheng A., Müller-Wieland D., Westerbacka J., Bosnyak Z., Lauand F. et al. Differential Glycaemic Control with Basal Insulin Glargine 300 U/mL versus Degludec 100 U/mL According to Kidney Function in Type 2 Diabetes: A Subanalysis from the BRIGHT Trial. Diabetes Obes Metab. 2020;22(8):1369–1377. https://doi.org/10.1111/dom.14043.
37. Freeman J. Management of Hypoglycemia in Older Adults with Type 2 Diabetes. Postgrad Med. 2019;131(4):241–250. https://doi.org/10.1080/00325481.2019.1578590.
38. Russell-Jones D., Dauchy A., Delgado E., Dimitriadis G., Frandsen H.A., Popescu L. et al. Take Control: A Randomized Trial Evaluating the Efficacy and Safety Of Self- versus Physician-Managed Titration of Insulin Glargine 300 U/mL in Patients with Uncontrolled Type 2 Diabetes. Diabetes Obes Metab. 2019;21(7):1615–1624. https://doi.org/10.1111/dom.13697.
39. Almalki M.H., Alshahrani F. Options for Controlling Type 2 Diabetes during Ramadan. Front Endocrinol (Lausanne). 2016;7:32. https://doi.org/10.3389/fendo.2016.00032.
40. Hassanein M., Akif Buyukbese M., Malek R., Pilorget V., Naqvi M., Berthou B. et al. Real-World Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Who Fast during Ramadan: The Observational ORION Study. Diabetes Res Clin Pract. 2020;166:108189. https://doi.org/10.1016/j.diabres.2020.108189.
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For citations:
Biryukova EV, Shinkin MV, Mikheeva OM. Long-acting insulin analogue in the treatment of type 2 diabetes mellitus: emphasis on proven efficacy and safety. Meditsinskiy sovet = Medical Council. 2021;(12):246-255. (In Russ.) https://doi.org/10.21518/2079-701X-2021-12-246-255
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