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

Abstract

Background: The rise in the burden of type 2 diabetes mellitus (T2DM) is causing global concern, especially in low-income countries. In addition, the American Diabetes Association recommends the use of DPP-4 inhibitors in combination with metformin. 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, single-arm 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 middle-aged 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 is effective, safe, and well-tolerated in managing T2DM in Iraqi patients≥18 years.