Abstract
INTRODUCTION: Teneligliptin is an antidiabetic medication that has been approved for the management of type 2 diabetes mellitus (T2DM) in Japan, South Korea and India. It is one of the most commonly prescribed antihyperglycaemic agents. The aim of this study was to assess the effectiveness of teneligliptin in improving glycemic control amongst Indian patients with T2DM in a real-world setting. METHODS: This was a retrospective observational study in which a predesigned structured proforma was used to collect information from hospital records of 18 medical centres across India. All participating centres were established primary care hospitals with adequate record keeping, a pre-determined condition in the study design. Data were collected during the period of January 2019 to June 2019. Data extracted from patient records, including glycaemic parameters, concomitant drugs, drug dosage and duration, were collated. The effectiveness of teneligliptin was assessed by analyzing the mean change in glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) at 12 weeks after initiation of teneligliptin. RESULTS: Data from 10,623 patients were available for analysis. The mean age of the enrolled patients was 51.86 ± 11.76 years. At 12 weeks after initiation of teneligliptin as monotherapy or add-on to other medications (combination therapy), the patients showed a signficant decrease from baseline in mean HbA1c, FPG and PPG. Mean HbA1c dropped from 8.66 ± 1.15% at baseline to 7.67 ± 1.28% at 12 weeks (71 ± 12.6 to 60 ± 14 mmol/mol), with a difference of - 0.99% (95% confidence interval [CI] 0.96-1.02) or - 10.8 (95% CI 10.5-11.1) mmol/mol (p < 0.0001). The mean reductions in FPG and PPG were 43.12 mg/dL (2.39 mmol/L) and 87.73 mg/dL (4.87 mmol/L) (both p < 0.0001) respectively. HbA1c (%) reductions with teneligliptin when used as add-on to metformin, add-on to metformin + sulfonylurea combination and add-on to metformin + sulfonylurea + alpha glucosidase inhibitor combination were 0.76% (8.3 mmol/mol), 1.24% (13.6 mmol/mol) and 1.04% (11.4 mmol/mol), respectively. Teneligliptin also significantly reduced HbA1c (1.13% or 12.4 mmol/mol, p < 0.0001) in patients with impaired renal function, without worsening the estimated glomerular filtration rate. Teneligliptin consistently reduced HbA1c across all three age categories tested-by 1% (10.9 mmol/mol) in patients aged < 60 years, by 1.15% (12.6 mmol/mol) in patients aged 60-75 years and by 0.88% (9.6 mmol/mol) in patients aged > 75 years. CONCLUSION: Teneligliptin significantly improved glycaemic parameters in Indian patients with T2DM when prescribed either as monotherapy or as an add-on to one or more other commonly prescribed antihyperglycaemic agents.