A prospective, randomised, open label study to compare efficacy and safety of hydroxychloroquine and teneligliptin in patients of type 2 diabetes mellitus refractory to concomitant metformin and glimepiride
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20230385Keywords:
Oral hypoglycemic agents, Sulfonylurea, Fasting blood glucose, Visual analogue scaleAbstract
Background: Diabetes mellitus is chronic, metabolic disease characterized by hyperglycemia, which over time causes both microvascular and macrovascular complications. If HbA1c target is not achieved with dual therapy then 3rd drug is added. Aims of present study were to compare efficacy and safety of Hydroxychloroquine (HCQ) and Teneligliptin in patients of T2DM who are refractory to concomitant Metformin and Glimepiride.
Methods: It was interventional, randomized, prospective, parallel and open-label study. Patients were randomly divided into 2 groups either HCQ 400mg OD or Teneligliptin 20mg OD were added to their current treatment using Metformin 1gm BD and Glimepiride 4 mg OD as 3rd drug. Follow up was done every 15 days for 12 weeks and underwent assessment of glycaemic parameters (FBS, PPG, HbA1c), LFT, RFT, CBC, ADRs and VAS in addition to anthropometric parameters.
Results: After 12 weeks of treatment, HCQ group showed statistically (p<0.05) better improvement in BMI than Teneligliptin group. Both groups showed comparable improvement (p>0.05) from baseline in FBS, HbA1c, PPG and VAS score. In HCQ group there was significant number (p<0.05) of patients who achieved target glycaemic control (HbA1c ≤7.5%) i.e., 56.6%, compared to 37% with Teneligliptin group. Both groups had comparable (p>0.05) safety profile with no serious adverse effects and no significant change (p>0.05) in hepatic, renal and complete blood profiles.
Conclusions: On the basis of effects of HCQ on the glycaemic parameters and BMI, HCQ may be preferred over Teneligliptin in patients of T2DM who are refractory to concomitant Metformin and Glimepiride.
References
Diabetes. Available at: https://www.who.int/news-room/fact-sheets/detail/diabetes. Accessed on 10 June 2021.
Ogurtsova K, da Rocha Fernandes JD, Huang Y, Linnenkamp U, Guariguata L, Cho NH, et al. IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017;128:40-50.
Zimmet P, Alberti KGMM, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001;414(6865):782-7.
Ramachandran A. Know the signs and symptoms of diabetes. Indian J Med Res. 2014;140(5):579-81.
Ganesan K, Sultan S. Oral hypoglycemic medications. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2019.
Gottschalk M, Danne T, Vlajnic A, Cara JF. Glimepiride Versus Metformin as Monotherapy in Pediatric Patients With Type 2 Diabetes: A randomized, single-blind comparative study. Diabetes Care. 2007;30(4):790-4.
Sharma SK, Panneerselvam A, Singh KP, Parmar G, Gadge P, Swami OC. Teneligliptin in management of type 2 diabetes mellitus. Diabetes Metab Syndr Obes. 2016;9:251-60.
Deogaonkar N. Hydroxychloroquine: a therapeutic choice in diabetes mellitus. J Diabetes Res. 2020;2020:5214751.
Jagnani VK, Bhattacharya NR, Satpathy SC, Hasda GC, Chakraborty S. Effect of hydroxychloroquine on type 2 diabetes mellitus unresponsive to more than two oral antidiabetic agents. J Diab Metab. 2017;8(10):1-6.
Pareek A, Chandurkar N, Thomas N, Viswanathan V, Deshpande A, Gupta OP, et al. Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes mellitus: a double blind, randomized comparison with pioglitazone. Curr Med Res Opin. 2014;30(7):1257-66.
Chakravarti HN, Nag A. Efficacy and safety of hydroxychloroquine as add-on therapy in uncontrolled type 2 diabetes patients who were using two oral antidiabetic drugs. J Endocrinol Invest. 2021;44(3):481-92.
Kumar A, Prakash AS. Effectiveness and Safety of Hydroxychloroquine compared to Teneligliptin in uncontrolled T2DM patients as add-on Therapy. J Asian Fed Endocr Soc. 2019;34(1):87-91.
Baidya A, Kumar M, Pathak SK, Ahmed R. Study of comparative effect of hydroxychloroquine and vildagliptin on glycaemic efficacy and HbA1c in type 2 diabetes patients who were inadequately controlled with metformin and glimepiride dual therapy. JMSCR. 2018;6(4):409-15.
Singh UP, Baidya A, Singla M, Jain S, Kumar S, Sarogi RK, et al. Efficacy and safety of substituting teneligliptin with hydroxychloroquine in inadequately controlled type 2 diabetes subjects with combination therapy of teneligliptin, metformin and glimepiride with or without other antidiabetic therapy. Clin Diabetol. 2018;7(5):209-14.
Hsia SH, Duran P, Lee ML, Davidson MB. Randomized controlled trial comparing hydroxychloroquine with pioglitazone as third-line agents in type 2 diabetic patients failing metformin plus a sulfonylurea: A pilot study. J Diabetes. 2020;12(1):91-4.
Diabetes. Available at: http://jmscr.igm.org/6-i4/68% 20jmscr.pdf. Accessed on 20 November 2022.
Baidya A, Ahmed R. Effect of early addition of hydroxychloroquine in type 2 diabetic patients inadequately controlled on metformin and sulfonylurea combination therapy. Int J Res Med Sci. 2018;6(8):2626.
Kumar V, Singh MP, Singh AP, Pandey MS, Kumar S, Kumar S. Efficacy and safety of hydroxychloroquine when added to stable insulin therapy in combination with metformin and glimepiride in patients with type 2 diabetes compare to sitagliptin. Int J Basic Clin Pharmacol. 2018;7(10):1959-64.
