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

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 at a high dose with inadequately controlled type 2 DM subjects in India. The study results also indicate the good tolerance of this drug with no critical adverse event in this study design.