Study to Determine the Safety and Efficacy of Teneligliptin (20 Mg) in Naive Type 2 Diabetes Mellitus
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Abstract
Background: Teneligliptin is a novel, highly selective DPP-4 inhibitor with long half-life, approved in Japan (2012) and in Korea (2014) to treat patients of type 2 DM. It is characterized by a considerably rigid structure formed by five consecutive rings. Teneligliptin, 20mg/day as monotherapy and combination therapy in type 2 DM was shown to be effective in reducing HbA1c and fasting plasma glucose levels without any significant adverse events. Present study was conducted to determine the safety and efficacy of Teneligliptin (20 mg) in naive type 2 diabetes mellitus.
Materials and methods: The present study was a hospital based prospective study undertaken to study the safety and efficacy of teneligliptin (20 mg) in naïve type 2 diabetes mellitus. Newly diagnosed type 2 diabetes mellitus patients within age group 18-70 years were studied. All patients were assessed for Blood sugar levels (Fasting and Postprandial HbA1C, Serum urea, Serum Creatinine, Serum uric acid, Lipid profile and ECG.
Results: The mean age of total patients was 52.86 ±9.24 years. The mean HbA1c among patients with DM was 7.76 ±1.61. The mean serum urea was 29.12±6.58mg/dl while Serum creatinine was 1.08±0.18 mg/dl. The mean fasting Blood sugar of the patients before treatment was 123.55 ±10.72 and 103.12 ±8.63 mg/dl after treatment with statistical significant difference (p<0.05). The mean blood urea of the patients before treatment was 29.12 ±6.58 and 20.86 ±5.04 mg/dl after treatment with no statistical significant difference. (p >0.05) The mean QT interval of the patients before treatment was 0.37±0.03 and 0.38±0.03 seconds after treatment with statistical non-significant difference (p <0.05).
Conclusion: The present study concludes that, Teneligliptin, a novel DPP-4I, when prescribed as a monotherapy antidiabetic agent in a dose of 20 mg daily, significantly improved glycemic parameters. The results of this study suggest that teneligliptin can be considered to be an effective antidiabetic agent in the management of Indian patients with type naive 2 Diabetes Mellitus.
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References
I. American Diabetes Association. Standards of Medical Care in Diabetes-2019. Diabetes Care 2019; 42(S1): S1-S193.
II. Kasper D, Fauci A, Hauser S, Longo D, Jameson J and Loscalzo J: Harrison’s principles of internal medicine McGraw-Hill Publisher, 19th edition 2015.
III. Ogurtsova K, da Rocha Fernandes JD, Huang Y, Linnenkamp U, Guariguata L, Cho NH, Cavan D, Shaw JE and Makaroff LE: IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Research and Clinical Practice 2017; 128: 40-50
IV. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E and Nauck M: Management of hyperglycemia in type 2 diabetes, 2015: a patientcentered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38(1): 140-9.
V. Nauck MA, Meininger G, Sheng DO, Terranella L and Stein PP: Efficacy and safety of the dipeptidyl peptidase4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, noninferiority trial. Diabetes, Obesity and Metabolism 2007; 9(2): 194-05.
VI. Nabeno M, Akahoshi F, Kishida H, Miyaguchi I, Tanaka Y and Ishii S: A comparative study of the binding modes of recently launched dipeptidyl peptidase IV inhibitors in the active site. Biochemical and Biophysical Research Communications 2013; 434(2): 191-6.
VII. Eto T, Inoue S and Kadowaki T: Effects of once daily teneligliptin on 24‐h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4week, randomized, double blind, placebo controlled trial. Diabetes, Obesity and Metabolism 2012; 14(11): 1040-6.
VIII. Singh AK: Efficacy and safety of teneligliptin. Indian J EndocrinolMetab 2017; 21(1): 11-17.
IX. Kutoh E, Hirate M and Ikeno Y: Teneligliptin as an initial therapy for newly diagnosed, drug naive subjects with type 2 diabetes. Jou of Clinical Med Res 2014; 6(4): 287-94.
X. Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert OpinPharmacother, 2015; 16: 971–981.
XI. Ghosh S, Trivedi S, Sanyal D, Modi KD, Kharb S. Teneligliptin real-world efficacy assessment of type 2 diabetes mellitus patients in India (TREATINDIA study). Diabetes, metabolic syndrome and obesity: targets and therapy. 2016;9:347.
XII. George M, Lincy Joseph, Venu Venkatappan3, Gayathri H. S., Joan John and SanjanaAugusthy. A prospective observational study on the analysis of utilisation pattern, safety and effectiveness of teneligliptin in type 2 diabetic patients with cardiovascular disease. World Journal of Pharmaceutical Research. 2018; 7 (19): 1199-1242.
XIII. Kishimoto M. Teneligliptin: a DPP-4 inhibitor for the treatment of type 2 diabetes. Diabetes MetabSyndrObes, 2013; 6: 187–195.
XIV. Hashikata T, Yamaoka-Tojo M, Kakizaki R, Nemoto T, Fujiyoshi K, Namba S, Kitasato L, Hashimoto T, Kameda R, Maekawa E, Shimohama T, Tojo T, Ako J. Teneligliptin improves left ventricular diastolic function and endothelial function in patients with diabetes. Heart Vessels, 2015.