A single -blind cross-over study of nateglinide and voglibose in combination with metformin in type 2 diabetes mellitus patients.q
Abstract
Diabetes mellitus is a major global health issue, affecting around 300 million people. Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by elevated blood sugar levels, primarily due to insulin resistance, which over time can damage organs and tissues. High postprandial blood glucose levels have been associated with atherosclerosis. This study aims to compare the efficacy and safety of nateglinide and voglibose in patients with T2DM. It is a single-blind, randomized crossover study involving patients from the General Medicine outpatient department. Patients were divided into Group A and Group B. Group A received nateglinide followed by voglibose, both with metformin. Group B received voglibose followed by nateglinide, also with metformin. In Group A, the baseline mean postprandial blood glucose (PPBG) was 237.81 ± 14.05 mg/dL. After 12 weeks of nateglinide and metformin, PPBG dropped to 193.25 ± 8.64, and further reduced to 171.63 ± 8.09 after voglibose and metformin. In Group B, the baseline PPBG was 237.67 ± 11.12, reduced to 195.27 ± 8.37 after nateglinide and metformin, and to 177.27 ± 8.64 after voglibose and metformin. Both groups showed a significant reduction in glycated hemoglobin (HbA1c) levels. While both drugs effectively reduced PPBG and HbA1c, voglibose demonstrated a better safety profile, with fewer hypoglycemic episodes compared to nateglinide. Therefore, although nateglinide and voglibose are equally effective in glycemic control, voglibose is considered safer.
Keywords:
Type 2 Diabetes mellitus, nateglinide, voglibose, metformin, crossover design, postprandial hyperglycemiaDOI
https://doi.org/10.22376/ijpbs.v16i2.44References
1. Al-AdsaniAM, Abdulla KA. Reasons for hospitalizations in adults withdiabetes in Kuwait. International Journal of Diabetes Mellitus. 2015 May31;3(1):65-9.
2. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Spectrum. 2012 Aug 1;25(3):154-71.
3. Mayor S. People with diabetes have one third higher mortality risk thangeneral population, auditshows.BMJ.2015Jan30;350:h529
4. Home PD, Home EM. International Textbook of Diabetes Mellitus. DiabeticMedicine. 2005Oct1;22(10):1460.
5. Melmed S, Polonsky KS, Larsen PR, Kronenberg HM. Williams textbook ofendocrinology.ElsevierHealthSciences; 2015Nov30.
6. Ayadurai S, Hattingh HL, Tee LB, Md Said SN. A narrative review of diabetes intervention studies to explore diabetes care opportunities for pharmacists. Journal of Diabetes Research. 2016;2016(1):5897452.
7. SadeghpourHeravi F, Zakrzewski M, Vickery K, G. Armstrong D, Hu H. Bacterial diversity of diabetic foot ulcers: current status and future prospectives. Journal of clinical medicine. 2019 Nov 10;8(11):1935.
8. Sagandira CR, Khasipo AZ, Sagandira MB, Watts P. An overview of the synthetic routes to essential oral anti-diabetes drugs. Tetrahedron. 2021 Sep 10;96:132378.
9. Prevention C. National diabetes statistics report. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services. 2020.
10. Kataoka Y, Yasuda S, Miyamoto Y, Sase K, Kosuge M, Kimura K, et al. DIANA study investigators. Effects of voglibose and nateglinide on glycemic status and coronary atherosclerosis in early-stage diabetic patients. Circ J. 2012;76:712–720. https:// doi.org/10.1253/circj.cj-11-1011.
11. Laiteerapong N, Ham SA, Gao Y, Moffet HH, Liu JY, Huang ES, et al. The legacy effect in type 2 diabetes: impact of early glycemic control on future complications (The Diabetes & Aging Study). Diabetes Care. 2018;42:416–426. https://doi.org/ 10.2337/dc17-1144
12. Edgar L, Akbar N, Braithwaite AT, Krausgruber T, Gallart-Ayala H, Bailey J, et al. Hyperglycemia induces trained immunity in macrophages and their precursors and promotes atherosclerosis. Circulation. 2021;144:961–982. https://doi.org/10.1161/ CIRCULATIONAHA.120.046464.
13. Kataoka Y, Yasuda S, Asaumi Y, Honda S, Noguchi T, Miyamoto Y, Sase K, Iwahashi N, Kawamura T, Kosuge M, Kimura K. Long-term effects of lowering postprandial glucose level on cardiovascular outcomes in early-stage diabetic patients with coronary artery disease: 10-year post-trial follow-up analysis of the DIANA study. Journal of Diabetes and its Complications. 2023 May 1;37(5):108469.
14. Kurebayashi S, Watada H, Tanaka Y, Kawasumi M, Kawamori R, Hirose T.Efficacyand adverseeffects ofnateglinidein earlytype2diabetes.Comparisonwithvogliboseinacross-over study.Endocrinejournal.2006;53(2):213-7.
15. Turner RC. The UK prospective diabetes study: a review. Diabetes care. 1998Dec1;21(Supplement3):C35-8.
16. Tanimoto M, Kanazawa A, Hirose T, Yoshihara T, Kobayashi‐Kimura S, Nakanishi R, Tosaka Y, Sasaki‐Omote R, Kudo‐Fujimaki K, Komiya K, Ikeda F. Comparison of sitagliptin with nateglinide on postprandial glucose and related hormones in drug‐naïve Japanese patients with type 2 diabetes mellitus: A pilot study. Journal of diabetes investigation. 2015 Sep 1;6(5):560- 6.
17. BinBH,SeoJ,Yang SH,Lee E,Choi H,KimKH,Cho EG, Lee TR.Novelinhibitory effect of the antidiabetic drug voglibose on melanogenesis.Experimentaldermatology.2013Aug 1;22(8):541-6.
18. ImamuraA, KusunokiM,UedaS,Hayashi N,Imai Y.ImpactofvogliboseonthepharmacokineticsofdapagliflozininJapanesepatientswithtype2diabetes.DiabetesTherapy.2013Jun1;4(1):41-9.
19. Raskin P,KlaffL, McGill J, SouthSA, Hollander P, KhutoryanskyN, HalePM.Efficacyand SafetyofCombinationTherapyRepaglinideplusmetforminversus nateglinideplusmetformin.DiabetesCare.2003Jul 1;26(7):2063-8.
20. Kinaan M, Ding H, Triggle CR. Metformin: an old drug for the treatment of diabetes but a new drug for the protection of the endothelium. Medical principles and practice, (2015); 24(5): 401-415.
21. Hussain A, Latif A, Rehmat Z, Riaz M, Jamil N, Amir M, Asif M. An updated review on anti-diabetic agents and their functions: a comparative study. Advancements in Life Sciences. 2023 Oct 23;10(3):326-34.
22. Wu P-C, Wu V-C, Lin C-J, Pan C-F, Chen C-Y, et al. Meglitinides increase the risk of hypoglycemia in diabetic patients with advanced chronic kidney disease: a nationwide, populationbased study. Oncotarget, (2017); 8(44): 78086
23. Hedrington MS, Davis SN. Considerations when using alphaglucosidase inhibitors in the treatment of type 2 diabetes. Expert opinion on pharmacotherapy, (2019); 20(18): 2229-2235.
24. Kashtoh H, Baek K-H. Recent Updates on Phytoconstituent Alpha-Glucosidase Inhibitors: An Approach towards the Treatment of Type Two Diabetes. Plants, (2022); 11(20): 2722.
Published

