© The Author(s). 2022 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/ by-nc/4.0/), which permits unrestricted use, distribution, and non-commercial reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons. org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. ORIGINAL ARTICLE A BSTRACT Aim: To study the efficacy of uptitrating the dose of Teneligliptin from 20 to 40 mg in patients with type II diabetes mellitus. Method: A retrospective, comparative analysis was undertaken in 853 type II diabetes mellitus patients (499 males and 354 females) who had follow-up records for more than 6 months. These patients were uncontrolled after use of atleast three oral antidiabetic drugs (OADs) and Teneligliptin 20 mg was added as the fourth drug. Patients who remained uncontrolled with the addition of 20 mg of Teneligliptin at the end of 3 months and were switched to receive 40 mg of Teneligliptin daily were included in this study. Results were analyzed at 3 and 6 months to ascertain efficacy of high-dose (40 mg) Teneligliptin. All other OADs remained the same in both groups. In all patients, the fasting blood glucose, postprandial blood glucose, and hemoglobin A1c (HbA1C) were evaluated and compared. Result: A total of 853 patients whose dose of Teneligliptin was increased from 20 to 40 mg were included in the study. At the end of 3 months after using Teneligliptin 40 mg, mean reduction in HbA1C was 0.5% (p-value 0.154). Similarly, mean reduction in fasting blood sugar (FBS) and postprandial blood sugar (PPBS) was 6.5 and 3.6 mg/dL, respectively (p-value 0.234 and 0.143). At the end of 6 months after using Teneligliptin 40 mg HbA1C showed no change but mean FBS and PPBS showed a modest reduction of 14.6 and 14 mg/dL, respectively (p-value < 0.001). Conclusion: The results of our study show that there was no statistically significant improvement in glycemic parameters when dose of Teneligliptin was increased from 20 to 40 mg at 3 months. But at 6 months, the FBS and PPBS showed a modest reduction of 14.6 and 14 mg/dL, respectively (p-value < 0.001) but the HbA1C showed no change. Journal of the Association of Physicians of India (2022): 10.5005/japi-11001-0051 1,2 Consultant, Lilavati Hospital & Research Centre; 3 Consultant Physician and Diabetologist, Shilpa Medical Research Centre; 4,6 Consultant, Dr Panikar’s Speciality Care Centre; 5 Assistant Professor, KJ Somaiya Medical College and Research Centre; 7,8 Student, Dr. Panikar’s Speciality Care Centre; 9–13 Student, Lilavati Hospital & Research Centre, Mumbai, Maharashtra, India; *Corresponding Author How to cite this article: Panikar V, Joshi S, Tiwaskar M, et al. Study of the Efficacy of Uptitrating Teneligliptin Dose from Standard Dose (20 mg) to High Dose (40 mg) in Patients with Type II Diabetes Mellitus. J Assoc Physicians India 2022;70(7):76–78. Study of the Efficacy of Uptitrating Teneligliptin Dose from Standard Dose (20 mg) to High Dose (40 mg) in Patients with Type II Diabetes Mellitus Vijay Panikar 1 , Shashank Joshi 2 , Mangesh Tiwaskar 3 , Amit Bhondve 4 , Nikhil Nasikkar 5 , Sanhita Walawalkar 6 , Ishita Sachdev 7 , Krish Panikar 8 , Khushbu Modh 9 , Pallavi Kulkarni 10 , Rahul Medidar 11 , Harshpreet Tuteja 12* , Sana Mansoori 13 Received: 28 July 2019; Revised: 21 December 2021; Accepted: 18 January 2022 standard approved by the USA National Glycohemoglobin Standardization Program. Study Endpoints Primary endpoint: Change in HbA1c from baseline to week 3 months after changing Teneligliptin 20–40 mg Secondary efficacy endpoints included changes in fasting plasma glucose (FPG), 2-h postprandial plasma glucose (PPG) baseline to 3 and 6 months. Inclusion Criterion • Patients who had records atleast 6 months or more of regular follow-ups. • Patients who had poor glycemic control despite taking Teneligliptin 20 mg in addition to three OADs (metformin, sulphonylureas, pioglitazone, or alpha-glucosidase inhibitors). (*poor glycemic control was defined as FPG ≥ 130 mg/dL, PPG ≥ 180 mg/dL, or HbA1c > 7.0). Exclusion Criterion • Patients who have been previously on DPP-4i. • Patients who were on insulin or previously were on insulin. Statistical Analysis Statistical testing was conducted with SPSS Statistics 23.0 (SPSS Inc., Chicago, Illinois, I NTRODUCTION D ipeptidyl peptidase-4 (DPP-4) inhibitors have recently emerged as a new class of antidiabetic drugs that show favorable results in improving glycemic control with minimal risk of hypoglycemia and weight gain. Teneligliptin has been reported to be a potent, long-lasting DPP-4 inhibitor 1 and is licensed in Japan for administration at standard (20 mg/day) and high (40 mg/day) doses for glycemic control. 2 Teneligliptin is currently used in cases showing insufficient improvement in glycemic control even after diet control and exercise or a combination of diet control, exercise, and metformin, sulfonylurea- or thiazolidine-class drugs. In adults, Teneligliptin is orally administered at a dosage of 20 mg once daily, which can be increased up to 40 mg per day. Because the metabolites of this drug are eliminated via renal and hepatic excretion, no dose adjustment is necessary in patients with renal impairment. The safety profile of Teneligliptin is similar to those of other available DPP-4 inhibitors. However, little is known about the efficacy of high-dose Teneligliptin (40 mg) compared to standard dose of Teneliglipitin (20 mg). M ETHOD A retrospective, comparative analysis was undertaken in 853 type II diabetes mellitus patients (499 males and 354 females) who had follow-up records for more than 6 months. These patients were uncontrolled after use of atleast three OADs and Teneligliptin 20 mg was added as the fourth drug. Patients who still remained uncontrolled with the addition of 20 mg of Teneligliptin at the end of 3 months and were switched to receive 40 mg of Teneligliptin daily were included in this study. Results were analyzed at 3 and 6 months to ascertain efficacy of high-dose (40 mg) Teneligliptin. All other OADs remained the same in both groups. In all patients the fasting blood glucose, postprandial blood glucose, and HbA1C were evaluated and compared. Hemoglobin A1c was measured by high-performance liquid chromatography using a reference