16-LB: Teneligliptin Observational Retrospective Real-World Study to Evaluate Its Effect on Renal Parameters and Safety in Indian Type 2 Diabetes Mellitus Patients with Chronic Kidney Disease (TOP RENAL)

Abstract

Background and Aim: Teneliglitpin, approved in India since 2015, is the most commonly prescribed DPP4i in India. Due to lack of evidence, this study was planned in real world setting to evaluate effects of teneligliptin on renal parameters and safety in Indian T2DM patients with CKD. Methodology: TOP RENAL real world study enrolled T2DM patients with eGFR ≤60 to ≥15 ml/min/1.73m2 and were started on teneligliptin (20/40 mg OD) and continued it for next six months. Those patients prescribed any antidiabetic medication along with teneligliptin or those with change in antidiabetic prescription in the following six months were excluded. Results: 377 patients data was collected during August'22-October'22 and grouped according to baseline eGFR (ml/min/1.73m2): G3a: 45-59 (n=102); G3b: 30-44 (n=124); G4: 15-29 (n=151). The mean age was 59.86±9.58 years and 47% were females. Renal parameters: eGFR, Sr creatinine and BUN were assessed at baseline, 3 months and 6 months. Results showed non-significant changes in eGFR (Table1), Sr. creatinine and BUN at 3 and 6 months in all three groups. No safety concerns or hypoglycemia were reported during the study. Conclusion: Teneligliptin initiation in Indian T2DM patients with mild-severe renal impairment did not show any safety concerns and was well tolerated. Disclosure S. Suryawanshi: Employee; Glenmark Pharmaceuticals. V. Jadhao: Employee; Glenmark Pharmaceuticals. M. Brid: Employee; Glenmark Pharmaceuticals. S. Bhushan: None. H. V. Barkate: None. Funding Glenmark Pharmaceuticals Limited