Shalini Kumar, Medical Affair Ajanta Pharma Ltd, India

Shalini Kumar

Medical Affair Ajanta Pharma Ltd, India

Presentation Title:

Real-World Observational Study in Patients on Teneligliptin/Teneligliptin + metformin Therapy for the Management of Type 2Diabetes Mellitus

Abstract

Background: The rise in the burden of type 2 diabetes mellitus (T2DM) is causing global concern, especially in low-income countries. Teneligliptin, a unique, potent, and long-lasting class 3 DPP-4 inhibitor with a half-life of approximately 24 h and unique pharmacokinetic properties. It is safe, well tolerated, and efficacious in diabetes, as monotherapy and in combination with several other antidiabetic agents, such as metformin etc. However, no studies using teneligliptin with or without metformin have been conducted in Iraqi patients with T2DM.  


Objective: To investigate the effects of teneligliptin in glycaemic control in patients with type 2 diabetes mellitus (T2DM) in Iraq.  


Methods: This was an open-label, multicentric, prospective, observational, post-marketing surveillance, singlearm study to observe the effect of teneligliptin monotherapy (Tiban®) and fixed-dose combination (FDC) with metformin (Tiban® M) on glycaemic control in real-world settings in Iraq. Patients aged ≥18 years diagnosed with T2DM with glycosylated haemoglobin (HbA1c) ≥6.5%, were included in the study. Results: A statistically significant reduction (p<0.0001) was observed in HbA1c, FBG and PPG at the end of 3 months. Change from baseline in PPG was statistically significant (p=0.029) among all age groups, with the greatest change in middleaged patients. There was no statistically significant change from the baseline values for HbA1c and FBG among different age group patients. In addition, there was no statistically significant difference from baseline HbA1c, FBG and PPG amongst patients in different BMI (Body mass index) groups. Nineteen adverse events were noted in 15 patients during the study. Seventeen events were mild, and two were moderate. No serious adverse events were reported in the patients included in this study.  


Conclusion: Teneligliptin, as monotherapy as well as in combination with metformin, demonstrated to be effective, safe, and well-tolerated in the management of T2DM in adult Iraqi patients of all age groups.

Biography

Shalini Kumar completed her MD in pharmacology from Patna University, India. Currently, she is heading the medical affairs department of a pharmaceutical company based in India. Her current designation is Vice president, medical affair. In her current role she is involved in conducting clinical trials, mainly PMS studies, new product evaluation etc. She has moderated International speaker programmes & has several publications. She is also a qualified auditor for the accreditation of Ethics committee in India.