Evaluation of the Safety and Efficacy of Teneligliptin at a Higher Dose in Indian Type 2 Diabetes Patients: A Retrospective Analysis

Abstract

Background and aim While diabetes mellitus (DM) is occupying the topmost global epidemic position, India is harboring a challenging number of type 2 DM patients in the world. This devastating picture of the health sector in India requires the availability of more cost-effective, context-specific, and safer drugs for DM management. This study aimed to evaluate the safety and efficacy of teneligliptin in Indian patients with type 2 DM inadequately controlled with diet, exercise, and a maximal dose of metformin treatment. Materials and methods This was a retrospective, observational, and single-center study conducted at a diabetic clinic in India in type 2 DM patients who have been treated with teneligliptin 40 mg once daily as add-on therapy with diet, exercise, and the maximal tolerable dose of metformin for three months. The study was observational, where the data collection was through self-reporting and an observational study conducted over one year (September 2018 to August 2019). A total of 100 patients were enrolled in the study (male 69% and female 31%). Patients with available data for fasting plasma glucose (FPG), postprandial plasma glucose (2h PPG), glycated hemoglobin (HbA1c), renal function parameters, such as urinary albumin to creatinine ratio (UACR), and electrocardiogram (ECG) at baseline and three months after treatment were enrolled in the study. Results There was a significant reduction in fasting blood sugar (P=<0.001), postprandial blood sugar (P=<0.001), and HbA1c (P=<0.001) at the end of the three months treatment in comparison to the baseline level and in the primary outcomes of this study as compared to baseline. The teneligliptin treatment did not cause any significant reduction in body mass index (BMI) before and after treatment. When we compared the secondary outcomes, the indicator of renal function as expressed through the albumin-to-creatinine ratio (ACR; P=0.052), there was a borderline change in ACR from baseline to three months. The mean corrected QT interval at screening baseline was 429.7 ± 8.89 milliseconds while after three months, it was 429.1 ± 8.68 milliseconds, which was statistically insignificant. Conclusion The current results demonstrated a high level of efficacy as an add-on therapy of teneligliptin 1 2

Optimizing the treatment of newly diagnosed type 2 diabetes mellitus with combination of dipeptidyl peptidase-4 inhibitors and metformin

“…Multiple studies have demonstrated significant reduction in FPG, PPBG and HbA 1C with no significant effects on QT/QTc interval prolongation by Teneligliptin. [ 70 71 ]…”

A Single-Center, Observational, Retrospective Cost-Effective Analysis of Treating Inadequately Controlled Type 2 Diabetes Mellitus by Addition of DPP4 Inhibitors Versus Intensified Treatment with Conventional Drugs

“…The result was similar to those reported by other studies like Gullapalli and Desai in a nonrandomized longitudinal intervention study from Karnataka found that the decrement in mean FBS was significantly more in the vildagliptin group than in the glimepiride group which was similar to their study. [14] Another study conducted by Chatterjee, [15] Mitra and Ray, [5] Charbonnel et al, [16] and Devarajan et. al.…”

“…Due to the unique mode of action on the glucose concentration and the low risk of hypoglycemia, DPP-4i has attracted a lot of research interests from basic science to clinical trials from pharmacokinetics to pharmacodynamics, including safety and efficacy. [5] The common practice in recent days is to either intensify the treatment with previously prescribed drugs such as metformin and glimepiride or to add DPP-4i like vildagliptin as add-on therapy when the previous ongoing therapy fails to achieve the target level of glycemic control. [6][7][8][9][10] Controlling the cost of treatment is a major issue, as it affects the national budget, and situation is worse in developing countries where resources are limited.…”

An Observational Retrospective Real-World Study to Evaluate the Effect of Teneligliptin on Parameters of Renal Function, Glycemic Control, and Safety in Indian T2DM Patients with Chronic Kidney Disease (TOP RENAL)

“…Sagar M, et al (2016) elucidated improvement in endothelial function and reduction in renal and vascular oxidative stress in patients with T2DM and CKD with the use of Teneligliptin [23]. Mitra A and Ray S (2020) demonstrated that marginal improvement of kidney function as expressed through a borderline change in the ACR (P = 0.052) from baseline to three months [24].…”