Evaluating gliclazide for the treatment of type 2 diabetes mellitus

References

• Kalyani RR, Solomon CG. Glucose-lowering drugs to reduce cardiovascular risk in type 2 diabetes. N Engl J Med. 2021;384(13):1248–1260.
   PubMed Web of Science ®Google Scholar
• Rawshani A, Rawshani A, Franzen S, et al. Risk factors, mortality, and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2018;379(7):633–644.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association Professional Practice Committee. 10. Cardiovascular disease and risk management: standards of medical care in diabetes—2022. Diabetes Care. 2022;45(Supplement_1):S144–S174.
   PubMedGoogle Scholar
• American Diabetes Association Professional Practice Committee. 9. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes—2022. Diabetes Care. 2022;45(Supplement_1):S125–S143.
   PubMedGoogle Scholar
• Khunti K, Godec TR, Medina J, et al. Patterns of glycaemic control in patients with type 2 diabetes mellitus initiating second-line therapy after metformin monotherapy: retrospective data for 10 256 individuals from the United Kingdom and Germany. Diabetes Obes Metab. 2018;20(2):389–399.
   PubMed Web of Science ®Google Scholar
• Montvida O, Shaw J, Atherton JJ, et al. Long-term trends in antidiabetes drug usage in the U.S.: real-world evidence in patients newly diagnosed with type 2 diabetes. Diabetes Care. 2018;41(1):69–78.
   PubMed Web of Science ®Google Scholar
• Curtis HJ, Dennis JM, Shields BM, et al. Time trends and geographical variation in prescribing of drugs for diabetes in England from 1998 to 2017. Diabetes Obes Metab. 2018;20(9):2159–2168.
   PubMed Web of Science ®Google Scholar
• Consoli A, Czupryniak L, Duarte R, et al., Positioning sulphonylureas in a modern treatment algorithm for patients with type 2 diabetes: expert opinion from a European consensus panel. 2020;Diabetes Obes Metab. 22(10):1705–1713.
   PubMed Web of Science ®Google Scholar
• Khunti K, Chatterjee S, Gerstein HC, et al. Do sulphonylureas still have a place in clinical practice? Lancet Diabetes Endocrinol. 2018;6(10):821–832.
   PubMed Web of Science ®Google Scholar
• Genuth S. Should sulfonylureas remain an acceptable first-line add-on to metformin therapy in patients with type 2 diabetes? No, it’s time to move on! Diabetes Care. 2015;38(1):170–175.
   PubMed Web of Science ®Google Scholar
• Zaccardi F, Khunti K, Marx N, et al., First-line treatment for type 2 diabetes: is it too early to abandon metformin? 2020;Lancet. 396(10264):1705–1707.
   PubMed Web of Science ®Google Scholar
• Thule PM, Umpierrez G. Sulfonylureas: a new look at old therapy. Curr Diab Rep. 2014;14(4):473.
   PubMed Web of Science ®Google Scholar
• Dornhorst A. Insulinotropic meglitinide analogues. Lancet. 2001;358(9294):1709–1716.
   PubMed Web of Science ®Google Scholar
• Hedrington MS, Davis SN. Considerations when using alpha-glucosidase inhibitors in the treatment of type 2 diabetes. Expert Opin Pharmacother. 2019;20(18):2229–2235.
   PubMed Web of Science ®Google Scholar
• Gale EAM. Troglitazone: the lesson that nobody learned? Diabetologia. 2006;49(1):1–6.
   PubMed Web of Science ®Google Scholar
• Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA. 2007;298(10):1189–1195.
   PubMed Web of Science ®Google Scholar
• Tomlinson B, Chan P, Lam CWK. An overview of alogliptin + pioglitazone for the treatment of type 2 diabetes. Expert Opin Pharmacother. 2022;23(1):29–42.
   PubMed Web of Science ®Google Scholar
• Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317–1326.
   PubMed Web of Science ®Google Scholar
• Gerich JE, Wood AJJ, Gerich JE. Oral hypoglycemic agents. N Engl J Med. 1989;321(18):1231–1245.
   PubMed Web of Science ®Google Scholar
• Colagiuri S, Matthews D, Leiter LA, et al. The place of gliclazide MR in the evolving type 2 diabetes landscape: a comparison with other sulfonylureas and newer oral antihyperglycemic agents. Diabetes Res Clin Pract. 2018;143:1–14.
   PubMed Web of Science ®Google Scholar
• Lang V, Light PE. The molecular mechanisms and pharmacotherapy of ATP-sensitive potassium channel gene mutations underlying neonatal diabetes. Pharmgenomics Pers Med. 2010;3:145–161.
   PubMedGoogle Scholar
• Harrower A. Gliclazide modified release: from once-daily administration to 24-hour blood glucose control. Metabolism. 2000;49(10, Supplement 2):7–11.
   PubMed Web of Science ®Google Scholar
• McGavin JK, Perry CM, Goa KL. Gliclazide modified release. Drugs. 2002;62(9):1357–1364.
   PubMedGoogle Scholar
• Abdelmoneim AS, Hasenbank SE, Seubert JM, et al. Variations in tissue selectivity amongst insulin secretagogues: a systematic review. Diabetes Obes Metab. 2012;14(2):130–138.
   PubMed Web of Science ®Google Scholar
• Riveline JP, Danchin N, Ledru F, et al. Sulfonylureas and cardiovascular effects: from experimental data to clinical use. Available data in humans and clinical applications. Diabetes Metab. 2003;29(3):207–222.
   PubMed Web of Science ®Google Scholar
• Schernthaner G. Gliclazide modified release: a critical review of pharmacodynamic, metabolic, and vasoprotective effects. Metabolism. 2003;52(8 Suppl 1):29–34.
   PubMed Web of Science ®Google Scholar
• Gribble FM, Ashcroft FM. Differential sensitivity of beta-cell and extrapancreatic K(ATP) channels to gliclazide. Diabetologia. 1999;42(7):845–848.
   PubMed Web of Science ®Google Scholar
• Ashcroft FM, Gribble FM. Tissue-specific effects of sulfonylureas: lessons from studies of cloned K(ATP) channels. J Diabetes Complications. 2000;14(4):192–196.
   PubMed Web of Science ®Google Scholar
• Wascher TC, Boes U. Forearm vascular reactivity is differentially influenced by gliclazide and glibenclamide in chronically treated type 2 diabetic patients. Clin Physiol Funct Imaging. 2005;25(1):40–46.
   PubMed Web of Science ®Google Scholar
• Noda Y, Mori A, Cossins E, et al. Gliclazide scavenges hydroxyl and superoxide radicals: an electron spin resonance study. Metabolism. 2000;49(2 Suppl 1):14–16.
   PubMed Web of Science ®Google Scholar
• Fava D, Cassone-Faldetta M, Laurenti O, et al. Gliclazide improves antioxidant status and nitric oxide-mediated vasodilation in type 2 diabetes. Diabet Med. 2002;19(9):752–757.
   PubMed Web of Science ®Google Scholar
• Sawada F, Inoguchi T, Tsubouchi H, et al. Differential effect of sulfonylureas on production of reactive oxygen species and apoptosis in cultured pancreatic β-cell line, MIN6. Metabolism. 2008;57(8):1038–1045.
   PubMed Web of Science ®Google Scholar
• Satoh J, Takahashi K, Takizawa Y, et al. Secondary sulfonylurea failure: comparison of period until insulin treatment between diabetic patients treated with gliclazide and glibenclamide. Diabetes Res Clin Pract. 2005;70(3):291–297.
   PubMed Web of Science ®Google Scholar
• Harrower AD. Comparison of efficacy, secondary failure rate, and complications of sulfonylureas. J Diabetes Complications. 1994;8(4):201–203.
   PubMed Web of Science ®Google Scholar
• Hosker JP, Rudenski AS, Burnett MA, et al. Similar reduction of first- and second-phase B-cell responses at three different glucose levels in type II diabetes and the effect of gliclazide therapy. Metabolism. 1989;38(8):767–772.
   PubMed Web of Science ®Google Scholar
• Hirst JA, Farmer AJ, Dyar A, et al. Estimating the effect of sulfonylurea on HbA1c in diabetes: a systematic review and meta-analysis. Diabetologia. 2013;56(5):973–984.
   PubMed Web of Science ®Google Scholar
• Kobayashi K, Kimura M, Sakoguchi T, et al. Influence of blood proteins on biomedical analysis. III. Pharmacokinetics and protein binding of gliclazide. J Pharmacobiodyn. 1981;4(6):436–442.
   PubMedGoogle Scholar
• Campbell DB, Lavielle R, Nathan C. The mode of action and clinical pharmacology of gliclazide: a review. Diabetes Res Clin Pract. 1991;14 (Suppl 2):S21–36.
   PubMed Web of Science ®Google Scholar
• Davis TM, Daly F, Walsh JP, et al. Pharmacokinetics and pharmacodynamics of gliclazide in Caucasians and Australian Aborigines with type 2 diabetes. Br J Clin Pharmacol. 2000;49(3):223–230.
   PubMed Web of Science ®Google Scholar
• Delrat P, Paraire M, Jochemsen R. Complete bioavailability and lack of food-effect on pharmacokinetics of gliclazide 30 mg modified release in healthy volunteers. Biopharm Drug Dispos. 2002;23(4):151–157.
   PubMed Web of Science ®Google Scholar
• Scheen AJ. Pharmacokinetic considerations for the treatment of diabetes in patients with chronic kidney disease. Expert Opin Drug Metab Toxicol. 2013;9(5):529–550.
   PubMed Web of Science ®Google Scholar
• Tomlinson B, Patil NG, Fok M, et al. The role of sulfonylureas in the treatment of type 2 diabetes. Expert Opin Pharmacother. 2022;23(3):387–403.
   PubMed Web of Science ®Google Scholar
• Shao H, Ren XM, Liu NF, et al. Influence of CYP2C9 and CYP2C19 genetic polymorphisms on pharmacokinetics and pharmacodynamics of gliclazide in healthy Chinese Han volunteers. J Clin Pharm Ther. 2010;35(3):351–360.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Si D, Chen X, et al. Influence of CYP2C9 and CYP2C19 genetic polymorphisms on pharmacokinetics of gliclazide MR in Chinese subjects. Br J Clin Pharmacol. 2007;64(1):67–74.
   PubMed Web of Science ®Google Scholar
• Zhou Y, Ingelman-Sundberg M, Lauschke VM. Worldwide distribution of cytochrome P450 alleles: a meta-analysis of population-scale sequencing projects. Clin Pharmacol Ther. 2017;102(4):688–700.
   PubMed Web of Science ®Google Scholar
• Chow E, Poon EWM, Fok BSP, et al. CYP2C19*2 polymorphism is associated with impaired oral clearance of gliclazide in healthy Chinese. Pharmgenomics Pers Med. 2019;12():397–401.
   PubMed Web of Science ®Google Scholar
• Wang K, Yang A, Shi M, et al. CYP2C19 loss-of-function polymorphisms are associated with reduced risk of sulfonylurea treatment failure in Chinese patients with type 2 diabetes. Clin Pharmacol Ther. 2021;111(2):461–469.
   PubMed Web of Science ®Google Scholar
• Chen Y, Chen L, Zhang H, et al. Interaction of sulfonylureas with liver uptake transporters OATP1B1 and OATP1B3. Basic Clin Pharmacol Toxicol. 2018;123(2):147–154.
   PubMed Web of Science ®Google Scholar
• Yang F, Xiong X, Liu Y, et al. CYP2C9 and OATP1B1 genetic polymorphisms affect the metabolism and transport of glimepiride and gliclazide. Sci Rep. 2018;8(1):10994.
   PubMedGoogle Scholar
• Dawed AY, Yee SW, Zhou K, et al. Genome-wide meta-analysis identifies genetic variants associated with glycemic response to sulfonylureas. Diabetes Care. 2021;44(12):2673–2682.
   PubMed Web of Science ®Google Scholar
• Wang K, Shi M, Yang A, et al. Comment on Dawed et al. genome-wide meta-analysis identifies genetic variants associated with glycemic response to sulfonylureas. diabetes care 2021;44:2673–2682. Diabetes Care. 2022;45(4):e80–e1.
   PubMedGoogle Scholar
• Dennis JM, Henley WE, Weedon MN, et al. Sex and BMI alter the benefits and risks of sulfonylureas and thiazolidinediones in type 2 diabetes: a framework for evaluating stratification using routine clinical and individual trial data. Diabetes Care. 2018;41(9):1844–1853.
   PubMed Web of Science ®Google Scholar
• Dennis JM, Shields BM, Henley WE, et al. Disease progression and treatment response in data-driven subgroups of type 2 diabetes compared with models based on simple clinical features: an analysis using clinical trial data. Lancet Diabetes Endocrinol. 2019;7(6):442–451.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. 2. Classification and diagnosis of diabetes: - standards of medical care in diabetes—2021. Diabetes Care. 2021;44(Supplement 1):S15–S33.
   PubMedGoogle Scholar
• Pearson ER, Starkey BJ, Powell RJ, et al. Genetic cause of hyperglycaemia and response to treatment in diabetes. Lancet. 2003;362(9392):1275–1281.
   PubMed Web of Science ®Google Scholar
• Pearson ER, Flechtner I, Njolstad PR, et al. Switching from insulin to oral sulfonylureas in patients with diabetes due to Kir6.2 mutations. N Engl J Med. 2006;355(5):467–477.
   PubMed Web of Science ®Google Scholar
• Pearson ER. Diabetes: is there a future for pharmacogenomics guided treatment? Clin Pharmacol Ther. 2019;106(2):329–337.
   PubMed Web of Science ®Google Scholar
• Pearson ER, Donnelly LA, Kimber C, et al. Variation in TCF7L2 influences therapeutic response to sulfonylureas: a GoDARTs study. Diabetes. 2007;56(8):2178–2182.
   PubMed Web of Science ®Google Scholar
• Javorsky M, Babjakova E, Klimcakova L, et al. Association between TCF7L2 genotype and glycemic control in diabetic patients treated with gliclazide. Int J Endocrinol. 2013;2013():374858.
   PubMed Web of Science ®Google Scholar
• Schroner Z, Javorsky M, Tkacova R, et al. Effect of sulphonylurea treatment on glycaemic control is related to TCF7L2 genotype in patients with type 2 diabetes. Diabetes Obes Metab. 2011;13(1):89–91.
   PubMed Web of Science ®Google Scholar
• Holmes B, Heel RC, Brogden RN, et al. Gliclazide. A preliminary review of its pharmacodynamic properties and therapeutic efficacy in diabetes mellitus. Drugs. 1984;27(4):301–327.
   PubMed Web of Science ®Google Scholar
• Guillausseau PJ, Greb W. 24-hour glycemic profile in type 2 diabetic patients treated with gliclazide modified release once daily. Diabetes Metab. 2001;27(2 Pt 1):133–137.
   PubMed Web of Science ®Google Scholar
• Drouin P, Diamicron®MR Study Group. Diamicron MR once daily is effective and well tolerated in type 2 diabetes: a double-blind, randomized, multinational study. J Diabetes Complications. 2000;14(4):185–191.
   PubMed Web of Science ®Google Scholar
• ADVANCE Collaborative GroupPatel A, MacMahon S, Chalmers J, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358(24):2560–2572.
   PubMed Web of Science ®Google Scholar
• Zoungas S, Chalmers J, Neal B, et al. Follow-up of blood-pressure lowering and glucose control in type 2 diabetes. N Engl J Med. 2014;371(15):1392–1406.
   PubMed Web of Science ®Google Scholar
• Vaccaro O, Masulli M, Nicolucci A, et al. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial. Lancet Diabetes Endocrinol. 2017;5(11):887–897.
   PubMed Web of Science ®Google Scholar
• Chan SP, Colagiuri S. Systematic review and meta-analysis of the efficacy and hypoglycemic safety of gliclazide versus other insulinotropic agents. Diabetes Res Clin Pract. 2015;110(1):75–81.
   PubMed Web of Science ®Google Scholar
• Landman GW, de Bock GH, van Hateren KJ, et al. Safety and efficacy of gliclazide as treatment for type 2 diabetes: a systematic review and meta-analysis of randomized trials. PLoS One. 2014;9(2):e82880.
   PubMed Web of Science ®Google Scholar
• Schernthaner G, Grimaldi A, Di Mario U, et al. GUIDE study: double-blind comparison of once-daily gliclazide MR and glimepiride in type 2 diabetic patients. Eur J Clin Invest. 2004;34(8):535–542.
   PubMed Web of Science ®Google Scholar
• Nichols GA, Gomez-Caminero A. Weight changes following the initiation of new anti-hyperglycaemic therapies. Diabetes Obes Metab. 2007;9(1):96–102.
   PubMed Web of Science ®Google Scholar
• Maloney A, Rosenstock J, Fonseca V. A model-based meta-analysis of 24 antihyperglycemic drugs for type 2 diabetes: comparison of treatment effects at therapeutic doses. Clin Pharmacol Ther. 2019;105(5):1213–1223.
   PubMed Web of Science ®Google Scholar
• Leiter LA, Shestakova MV, Satman I. Effectiveness of gliclazide MR 60 mg in the management of type 2 diabetes: analyses from the EASYDia trial. Diabetol Metab Syndr. 2018;10(30). DOI:10.1186/s13098-018-0331-8
   PubMedGoogle Scholar
• Pr DIAMICRON® MR - PRODUCT MONOGRAPH. 2019 September 12. https://pdf.hres.ca›dpd_pm
   Google Scholar
• Sultanpur C, Satyanarayana S, Reddy N, et al. Drug-drug interaction between pravastatin and gemfibrozil (Antihyperlipidemic) with Gliclazide (Antidiabetic) in Rats. J Young Pharm. 2010;2(2):152–155.
   PubMedGoogle Scholar
• Crepaldi G, Fioretto P. Gliclazide modified release: its place in the therapeutic armamentarium. Metabolism. 2000;49(10 Suppl 2):21–25.
   PubMed Web of Science ®Google Scholar
• Meinert CL, Knatterud GL, Prout TE, et al. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. Diabetes. 1970;19:789–830.
   PubMed Web of Science ®Google Scholar
• Simpson SH, Lee J, Choi S, et al. Mortality risk among sulfonylureas: a systematic review and network meta-analysis. Lancet Diabetes Endocrinol. 2015;3(1):43–51.
   PubMed Web of Science ®Google Scholar
• Rados DV, Pinto LC, Remonti LR, et al. The association between sulfonylurea use and all-cause and cardiovascular mortality: a meta-analysis with trial sequential analysis of randomized clinical trials. PLoS Med. 2016;13(4):e1001992.
   PubMed Web of Science ®Google Scholar
• Phung OJ, Scholle JM, Talwar M, et al. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010;303(14):1410–1418.
   PubMed Web of Science ®Google Scholar
• Cordiner RLM, Pearson ER. Reflections on the sulphonylurea story: a drug class at risk of extinction or a drug class worth reviving? Diabetes Obes Metab. 2019;21(4):761–771.
   PubMed Web of Science ®Google Scholar
• Cordiner RLM, Mari A, Tura A, et al., The impact of low-dose gliclazide on the incretin effect and indices of beta-cell function. 2021;J Clin Endocrinol Metab. 106(7):2036–2046.
   PubMed Web of Science ®Google Scholar
• Kalra S, Unnikrishnan AG, Bantwal G, et al. The position of gliclazide in the evolving landscapes and disease continuum of T2DM: a collaborative delphi survey-based consensus from India. Diabetes Ther. 2021;12(3):679–695.
   PubMed Web of Science ®Google Scholar
• Kalra S, Bahendeka S, Sahay R, et al. Consensus recommendations on sulfonylurea and sulfonylurea combinations in the management of type 2 diabetes mellitus - international task force. Indian J Endocrinol Metab. 2018;22(1):132–157.
   PubMedGoogle Scholar
• Khunti K, Hassanein M, Lee M-K, et al. Role of gliclazide MR in the management of type 2 diabetes: report of a symposium on real-world evidence and new perspectives. Diabetes Therapy. 2020;11(2):33–48.
   PubMed Web of Science ®Google Scholar