Teneligliptin real-world efficacy assessment of type 2 diabetes mellitus patients in India (TREAT-INDIA study)

Abstract

Background and aimsTeneligliptin was introduced in India in May 2015. It has gained popularity and is already widely prescribed in type 2 diabetes mellitus (T2DM). This “real life” data collection was conducted to assess the efficacy of teneligliptin in Indian T2DM patients.MethodsPredesigned structured proforma was used to collect information from the prescribing physicians regarding the efficacy of teneligliptin when prescribed as monotherapy as well as combination therapy with other antidiabetic drugs in T2DM patients. Information on the glycemic parameters at baseline prior to starting teneligliptin and at the end of 3 months therapy was collected. The efficacy was assessed by analyzing the mean change in 3-month values of glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial plasma glucose (PPG).ResultsData of 4305 patients was available for analysis. There was statistically significant improvement in mean HbA1c, FPG, and PPG with teneligliptin therapy. Means changes in HbA1c, FPG, and PPG were −1.37%±1.15%, 51.29±35.41 mg/dL, and 80.89±54.27 mg/dL, respectively. Subgroup analysis revealed that HbA1c (%) reduction with teneligliptin when used as monotherapy, add-on to metformin or add-on to metformin plus sulfonylureas combination, add-on to metformin plus alpha glucosidase inhibitor combination or add-on to insulin was 0.98±0.53, 1.07±0.83, 1.46±1.33, 1.43±0.80, and 1.55±1.05, respectively.ConclusionReal-world data suggests that teneligliptin significantly improves glycemic control in Indian patients with T2DM when prescribed either as monotherapy or as an add-on to one or more other commonly prescribed antidiabetic drugs.

Retrospective real-life efficacy assessment of teneligliptin in Indian T2DM patients

“…HbA1c reduced by 0.98%, 1.11%, 1.51%, 1.62% and 1.65% in patients receiving one drug therapy (teneligliptin monotherapy), two drugs, three drugs, four drugs and five drugs therapies with teneligliptin respectively. 8 The results of the present study showed that 8weeks of teneligliptin when added to metformin+ sulphonylurea + pioglitazone, as fourth agent, was shown to be effective in significantly reducing HbA1c, FPG and PPG levels in Indian patients with T2DM. HbA1c reduction, similar to this study was seen when Sitagliptin was added to Metformin+SUs combination in 52 week trial conducted by Mamza J et al 10 In another a 24-week trial, when T2DM patients (n=93), who were on optimum dosage of metformin and sulphonylurea, were additionally treated with 100mg sitagliptin daily, mean HbA1c was reduced by 0.41% (P<0.007) at the end of 6 months.…”

Role of teneligliptin in rural India as add-on third drug in patients with type 2 diabetes mellitus

“…Similar results were seen with other gliptins like sitagliptin and vildagliptin during real-life observational studies conducted in India and elsewhere. 2,[13][14][15][16] The reduction in glycemic parameters strongly correlated with baseline glycemic values, that is, higher the HbA1c at baseline; higher was the reduction at the end of 3 months. Reduction in FPG and PPG was observed relative to corresponding baseline values.…”

“…6 It is economical as compared with other gliptins (sitagliptin, saxagliptin, vildagliptin, and linagliptin) available in India. 2 The average age of the population was >58 years and a significant proportion of patients were above 60 years of age (26.60%). Mean baseline HbA1c level of 8.54% confirms the high prevalence of uncontrolled glycemic status in patients with T2DM patients in developing countries like India.…”

“…12 Teneligliptin, a DPP-4 inhibitor was added to the armamentarium for use in patients with type 2 diabetes in India. 2 In different clinical trials conducted in Japan, Korea, and India, it has been shown to be safe and effective in T2DM patients when used either as monotherapy and combination antidiabetic therapy. 6 It is economical as compared with other gliptins (sitagliptin, saxagliptin, vildagliptin, and linagliptin) available in India.…”

“…This high prevalence of comorbid conditions in this study is in accordance with previously reported studies done in India. 2,17 Patients with co-morbid conditions were on different antihypertensives, statins, anti-platelet monotherapy or combination therapy.…”