SITAGLIPTIN IN TYPE 2 DIABETES MANAGEMENT: A STUDY OF ADD ON THERAPY IN BALI, INDONESIA

Authors

  • ANAK AGUNG KETUT PURNAMA SARI Department of Pharmacy, Singasana Tabanan Regional Public Hospital, Bali, Indonesia. https://orcid.org/0009-0007-2889-5650
  • PHEBE HENDRA Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Sanata Dharma University, Yogyakarta, Indonesia.
  • DITA MARIA VIRGINIA Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Sanata Dharma University, Yogyakarta, Indonesia. https://orcid.org/0000-0003-0469-1913

DOI:

https://doi.org/10.22159/ajpcr.2025v18i12.57060

Keywords:

Antidiabetic, diabetes mellitus, sitagliptin, effectiveness, safety

Abstract

Objectives: Dipeptidyl peptidase-4 (DPP-4) inhibitors are gaining popularity in several hospitals across Bali, particularly among patients with specific comorbid conditions, as they are included in Indonesia’s National Formulary. In clinical practice, sitagliptin (SITA) is one of the most commonly used DPP-4 inhibitors. This observational study aims to assess the effectiveness of SITA as an add-on therapy in the treatment of Type 2 Diabetes Mellitus (T2DM) in Bali.

Methods: A hospital-based observational study was carried out at four different hospitals in Bali over the course of 2024. Data were obtained from the medical records of T2DM outpatients. Of the 354 medical records, 156 samples were obtained and categorized into four treatment regimens, including three groups receiving SITA as an add-on therapy and one comparator group (metformin+sulfonyl urea [SU]). Demographic and glycemic parameters were analyzed using ANOVA and post hoc Tukey Test.

Results: A significant difference was observed in the mean Hemoglobin A1c (HbA1c), HbA1c reduction, fasting plasma glucose reduction, and random plasma glucose (RPG) levels across the groups, with p-values of 0.04, 0.00, 0.03, and 0.03, respectively. Post hoc test showed that the combination of metformin and SITA was superior to reduce HbA1c compared to SU and SITA (p=0.04). The highest incidence of hypoglycemia was found in the Metformin and SU combination group, with 16.7%. However, there was no significant association between SITA and hypoglycemia statistically.

Conclusion: As a second- or third-line therapy, SITA therapy is effective in significantly lowering HbA1c and RPG levels, while also reducing the risk of hypoglycemia.

Downloads

Download data is not yet available.

References

1. Hematyar J, Rashidi H, Zakerkish M, Payami SP, Ghaderian SB. Effect of sitagliptin versus glibenclamide on glycemic markers, lipid profile inflammatory and oxidative stress factors in type 2 diabetes patients: A double-blinded randomized controlled trial. Maedica (Buchar). 2022 Nov;17(4):762-70. doi: 10.26574/maedica.2022.17.4.762. PMID 36818268, PMCID PMC9923081

2. Indonesia Endocrinology Association. Guidelines for management and prevention of type 2 diabetes mellitus in adults in Indonesia. PB PERKENI, Jakarta; 2021.

3. Al-Azzam N, Al-Azzam S, Khassawneh B, Araydah M, Karasneh RA, Aldeyab MA. Factors contributing to poor COVID-19 outcomes in diabetic patients: Findings from a single-center cohort study. PLOS One. 2023;18(8):e0290946. doi: 10.1371/journal.pone.0290946, PMID 37651383

4. Pramesti NK, Kusumayanti GA, Ambartana IW, Juniarsana IW. Description of vegetables and fruits consumption patterns and blood sugar level in type 2 diabetes patients at public health center I West Denpasar. ICMAHS. 2023 Nov;1:46-55.

5. National Health Research. Bali Provincial Report. Jakarta: National Health Research; 2018.

6. Soeatmadji DW, Rosandi R, Saraswati MR, Sibarani RP, Tarigan WO. Clinicodemographic profile and outcomes of type 2 diabetes mellitus in the Indonesian cohort of Discover: A 3-year prospective cohort study. J Asean Fed Endocr Soc. 2023 Jan;38(1):68-74. doi: 10.15605/ jafes.038.01.10, PMID 37252407

7. D’Andrea E, Wexler DJ, Kim SC, Paik JM, Alt E, Patorno E. Comparing effectiveness and safety of SGLT2 inhibitors vs DPP- 4 inhibitors in patients with type 2 diabetes and varying baseline HbA1c levels. JAMA Intern Med. 2023;183(3):242-54. doi: 10.1001/ jamainternmed.2022.6664, PMID 36745425

8. Kisioglu SV, Can O, Tekin S, Sargin M. Sitagliptin add-on to metformin plus sulphonylurea combination therapy: The efficacy of triple therapy on metabolic and glycemic control in type 2 diabetes. Anatol J Fam Med. 2021 Aug;4:165-9. doi: 10.5505/anatoljfm.2021.87049

9. Ministry of Health of the Republic of Indonesia. Decree of the Minister of Health of the Republic of Indonesia Number HK.01.07/ MENKES/2197/2023 Concerning National Formulary. Jakarta: Ministry of Health of the Republic of Indonesia; 2023.

10. Badyal DK, Sitagliptin KJ. A new class of oral drug for type 2 diabetes. JK Sci. 2008;10(2):97-8.

11. Green BD, Flatt PR, Bailey CJ. Dipeptidyl peptidase IV (DPP IV) inhibitors: A newly emerging drug class for the treatment of type 2 diabetes. Diab Vasc Dis Res. 2006;3(3):159-65. doi: 10.3132/ dvdr.2006.024, PMID 17160910

12. Sakamoto M, Nishimura R, Irako T, Tsujino D, Ando K, Utsunomiya K. Comparison of vildagliptin twice daily vs. sitagliptin once daily using continuous glucose monitoring (CGM): Crossover pilot study (J-VICTORIA study). Cardiovasc Diabetol. 2012;11:92. doi: 10.1186/1475-2840-11-92, PMID 22867630

13. Alsaidan AA, Alsaidan OA, Mallhi TH, Khan YH, Alzarea AI, Alanazi AS. Assessment of adherence to insulin injections among diabetic patients on basal-bolus regimen in primary and secondary healthcare centers in al-jouf region of Saudi Arabia; A descriptive analysis. J Clin Med. 2023;12(10):3474. doi: 10.3390/jcm12103474, PMID 37240580

14. Engel SS, Suryawanshi S, Stevens SR, Josse RG, Cornel JH, Jakuboniene N, et al. Safety of sitagliptin in patients with type 2 diabetes and chronic kidney disease: Outcomes from TECOS. Diabetes Obes Metab. 2017 Nov;19(11):1587-93. doi: 10.1111/dom.12983, PMID 28432745

15. Moses RG, Round E, Shentu Y, Golm GT, O’neill EA, Gantz I, et al. A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control. J Diabetes. 2016;8(5):701-11. doi: 10.1111/1753-0407.12351, PMID 26625270

16. Hayati F, Hazim A, Sasongko TH, Siew Hua G, Wan Mohamed WM, Daud J, et al. Efficacy and safety of sitagliptin as a third therapeutic agent in the treatment of type 2 diabetes mellitus. J Diab Res Clin Met. 2014;3(1):10. doi: 10.7243/2050-0866-3-10

17. Sotoudeheian M, Mirahmadi SM, Salehi Darjani P, Moradi M, Pirhayati M, Dakkali MS, et al. Sitagliptin, diabetes mellitus, and heart failure: An in-depth review of sitagliptin therapy and heart failure in patients with diabetes mellitus. Diabetol Int. 2025 Apr;16(2):237-56. doi: 10.1007/s13340-025-00800-6, PMID 40166434

18. Wadie W, Ahmed GS, Shafik AN, El-sayed M. Effects of insulin and sitagliptin on early cardiac dysfunction in diabetic rats. Life Sci. 2022 Jun;299:120542. doi: 10.1016/j.lfs.2022.120542, PMID 35395243

19. American Diabetes Association Professional Practice Committee. 9. Pharmacologic approaches to glycemic treatment: Standards of care in diabetes - 2024. Diabetes Care. 2024 Jan;47(1) Suppl 1:S158-78. doi: 10.2337/dc24-S009, PMID 38078590

20. Kadowaki T, Tajima N, Odawara M, Nishii M, Taniguchi T, Ferreira JC. Addition of sitagliptin to ongoing metformin monotherapy improves glycemic control in Japanese patients with type 2 diabetes over 52 weeks. J Diabetes Investig. 2013 Mar;4(2):174-81. doi: 10.1111/ jdi.12001, PMID 24843649

21. Arsana BS, Bagiansah M, Zoraya SI, Azhar MB. Association of body mass index, age, and sex with blood glucose levels in type 2 diabetes mellitus patients. J Biol Trop. 2024;24:567-74.

22. Natasya A, Andrajati R, Sauriasari R. Cross-sectional study of association between glycemic control and quality of life among diabetic patients. Int J Appl Pharm. 2018;10(1):92-6. doi: 10.22159/ijap.2018. v10s1.19

23. Tanjung R, Wardati Y, Saptarini NM. Cost-effectiveness analysis of prolanis of type 2 diabetes mellitus patients on three community health centers in Bandung, Indonesia. Int J Appl Pharm. 2021;13(3):28-31. doi: 10.22159/ijap.2021.v13s3.05

24. Nagao M, Sasaki J, Sugihara H, Tanimura-Inagaki K, Harada T, Sakuma I, et al. Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: The stream study. Sci Rep. 2023;13(1):134. doi: 10.1038/s41598-022-27301-9, PMID 36599895

25. Noh J. Pharmacological management of diabetes in older adults. CardioVasc Prev Pharmacother. 2025 Jan;7(1):13-20. doi: 10.36011/ cpp.2025.7.e1

26. Gray N, Picone G, Sloan F, Yashkin A. Relation between BMI and diabetes mellitus and its complications among US older adults. South Med J. 2015;108(1):29-36. doi: 10.14423/SMJ.0000000000000214, PMID 25580754

27. Durlach V, Vergès B, Al-Salameh A, Bahougne T, Benzerouk F, Berlin I, et al. Smoking and diabetes interplay: A comprehensive review and joint statement. Diabetes Metab. 2022;48(6):101370. doi: 10.1016/j. diabet.2022.101370, PMID 35779852

28. Bellanca CM, Augello E, Di Benedetto G, Burgaletto C, Cantone AF, Cantarella G, et al. A web-based scoping review assessing the influence of smoking and smoking cessation on antidiabetic drug meabolism: Implications for medication efficacy. Front Pharmacol. 2024;15:1406860. doi: 10.3389/fphar.2024.1406860, PMID 38957391

29. Virginia DM, Wahyuningsih MS, Nugrahaningsih DA. Association between three variants in the PRKAA2 gene, rs2796498, rs9803799, and rs2746342, with 10-year ASCVD risk on newly diagnosed T2DM in Yogyakarta, Indonesia. Open Access Maced J Med Sci. 2021 Aug;9(A):541-7. doi: 10.3889/oamjms.2021.6213

30. Virginia DM, Patramurti C, Fenty SC, Setiawan CH, Julianus J, Hendra P, et al. Single nucleotide polymorphism in the 3’ untranslated region of PRKAA2 on cardiometabolic parameters in type 2 diabetes mellitus patients who received metformin. Ther Clin Risk Manag. 2022 Apr;18:349-57. doi: 10.2147/TCRM.S349900, PMID 35414746

31. Ingle Pravinkumar V, Talele Gokul S. Adverse effects of metformin in combination with glimepiride and glibenclamide in patients with type 2 diabetes mellitus. Asian J Pharm Clin Res. 2012;5 Suppl 1:108-10.

32. Arechavaleta R, Seck T, Chen Y, Krobot KJ, O’Neill EA, Duran L, et al. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: A randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011;13(2):160-8. doi: 10.1111/j.1463- 1326.2010.01334.x, PMID 21199268

33. Tajima N, Eiki JI, Okamoto T, Okuyama K, Kawashima M, Engel SS. Factors associated with the glucose-lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials. J Diabetes Investig. 2020;11(3):640-6.

34. Patel DD, Arya N, Marko JL, Jagat RS, Kerkatta PJ, Churihar R. To study the efficacy and safety of sitagliptin in patients with type- 2 diabetes mellitus. J Popul Ther Clin Pharmacol. 2024 Nov;31(11): 416-28. doi: 10.53555/t0jc4838

35. Kim SA, Shim WH, Lee EH, Lee YM, Beom SH, Kim ES, et al. Predictive clinical parameters for the therapeutic efficacy of sitagliptin in Korean type 2 diabetes mellitus. Diabetes Metab J. 2011;35(2):159- 65. doi: 10.4093/dmj.2011.35.2.159, PMID 21738898

36. Srivastava KK, Kumar A, Singh M, Singh AP. Metformin - sitagliptin combination shows superior glycemic control and renal safety over metformin monotherapy: A comparative study. Int J Curr Pharm Rev Res. 2025;17(7):593-7.

37. Sahin I, Bakiner O, Demir T, Sari R, Atmaca A. Current position of gliclazide and sulfonylureas in the contemporary treatment paradigm for type 2 diabetes: A scoping review. Diabetes Ther. 2024 Aug;15(8):1687- 716. doi: 10.1007/s13300-024-01612-8, PMID 38935188

38. Sarkar A, Tiwari A, Bhasin PS, Mitra M. Pharmacological and pharmaceutical profile of gliclazide: A review. J Appl Pharm Sci. 2011 Nov;1(9):11-9.

39. Cordiner RL, Bedair K, Mari A, Pearson E. Low-dose sulfonylurea plus DPP4 inhibitor lower blood glucose and enhance beta-cell function without hypoglycemia. J Clin Endocrinol Metab. 2024 Jul;109(8):2106- 15. doi: 10.1210/clinem/dgae033, PMID 38267622

40. Ikawati Z, Adi Jaya MK, Rahmawati F, Yasin NM. Evaluation of insulin and sulfonylurea types on severe hypoglycemia event among ambulatory type 2 diabetes mellitus patients. A case-control hospital-based study in Bali. Biomed Pharmacol J. 2024 Dec;17(4):2249-57. doi: 10.13005/bpj/3021

41. Nguyen NC, Pham HT, Pham DT, Hoang TM, Dam TP, Ho TH, et al. Comparison of 3 medicine groups used to control glycemic and glycated hemoglobin levels in newly diagnosed type 2 diabetes patients. Open Access Maced J Med Sci. 2021 Jan;9(B):101-6. doi: 10.3889/oamjms.2021.4672

42. Mishra RK, Dhole S. Dipeptidyl peptidase-4 inhibitors: Potential for treatment of metabolic syndrome and developed formulation approaches. Asian J Pharm Clin Res. 2017;10(11):20-6. doi: 10.22159/ ajpcr.2017.v10i11.20342

Published

07-12-2025

How to Cite

ANAK AGUNG KETUT PURNAMA SARI, et al. “SITAGLIPTIN IN TYPE 2 DIABETES MANAGEMENT: A STUDY OF ADD ON THERAPY IN BALI, INDONESIA”. Asian Journal of Pharmaceutical and Clinical Research, vol. 18, no. 12, Dec. 2025, pp. 115-9, doi:10.22159/ajpcr.2025v18i12.57060.

Issue

Section

Original Article(s)