Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Background: Teneligliptin is a 3rd-generation dipeptidyl peptidase-4 (DPP-4) inhibitor. There is a limited evidence regarding the effect of teneligliptin. Therefore, this study is to assess the efficacy and safety of teneligliptin in type 2 diabetes mellitus (T2DM) patients with inadequately glycemic controlled.Methods: A search of PubMed, Medline, Embase, and The Cochrane Library during 2000.01–2018.03 was performed for randomized controlled trials of teneligliptin compared to placebo in patients with T2DM with monotherapy or add-on treatment.Results: Ten trials with 2119 patients were analyzed. Teneligliptin produced absolute reductions in glycated hemoglobin A1c (HbA1c) levels (weighted mean difference (WMD) 0.82%, 95% confidence interval (CI) [−0.91 to −0.72], p < 0.00001) compared with placebo. However, after 36–42 weeks of follow-up (open-label), HbA1c level rise higher than duration (double-blind) in teneligliptin group. Teneligliptin led to greater decrease of fasting plasma glucose (FPG) level (vs. placebo, WMD −18.32%, 95% CI [−21.05 to −15.60], p < 0.00001). Teneligliptin also significantly decreased the 2 h post-prandial plasma glucose (2 h PPG) (WMD −46.94%, 95% CI [−51.58 to −42.30], p < 0.00001) and area under the glucose plasma concentration-time curve from 0 to 2 h (AUC0−2h) for PPG (WMD −71.50%, 95% CI [−78.09 to −64.91], p < 0.00001) compared with placebo. Patients treated with teneligliptin achieved increased homeostasis model assessment of β cell function (HOMA-β) with 9.31 (WMD, 95% CI [7.78–10.85], p < 0.00001). However, there was no significant difference between teneligliptin and placebo in overall adverse effects (0.96 risk ratio (RR), 95% CI [0.87, 1.06], p = 0.06). The risks of hypoglycemia were not significantly different between teneligliptin and placebo (1.16 RR, 95% CI [0.59, 2.26], p = 0.66).Conclusions: Teneligliptin improved blood glucose levels and β-cells function with low risk of hypoglycemia in patients with T2DM. Common adverse effects of teneligliptin including hypoglycemia were identified and reviewed. Risks of cardiovascular events are less certain, and more data for long-term effects are needed.

Teneligliptin Real-World Effectiveness Assessment in Patients with Type 2 Diabetes Mellitus in India: A Retrospective Analysis (TREAT-INDIA 2)

“…Changes in HbA1c, FPG and PPG from baseline to end of the study (after 8 weeks of teneligliptin therapy) were -1.22 ± 1.12% or -13.3 ± 12.2 mmol/mol (p = 0.001), -35.8 ± 25.5 mg/dL or -1.99 ± 1.42 mmol/L (p = 0.001) and -60.7 ± 28.6 mg/dL or -3.37 ± 1.59 mmol/L (p = 0.001), respectively. The effectiveness of teneligliptin was also highlighted by Li et al [15] in a systematic meta-analysis of ten randomized controlled trials (RCTs) in which teneligliptin significantly (p \ 0.00001) decreased HbA1c (0.82% or 9.0 mmol/mol), FPG (18.32 mg/dL or 1.02 mmol/L) and PPG (46.94 mg/dL or 2.61 mmol/L). These data lead to the conclusion that teneligliptin effectively improves glycaemic control and is useful in the management of hyperglycaemia in patients with T2DM.…”

Glycemic and Non-Glycemic Effects of Teneligliptin

“…The area under the curve (AUC)0-2h values for the postprandial insulin levels significantly increased after dinner in the teneligliptin 10 mg group (P < 0.05), in comparison with the corresponding values in the placebo group, but not at other times in either group. The relative insulin concentrations were higher in the teneligliptin-treated groups because of the decreased blood glucose concentrations of the patients in these groups [9].…”

Efficacy and Safety of Teneligliptin as Add-on Therapy to Conventional Therapy in Indian Patients With Type 2 Diabetes Mellitus

“…Although, International American Diabetes Association and local guideline recommended lifestyle management as the mainstay of treatment for T2DM; with metformin as the preferred initial oral antihyperglycemic agent in most of patients, there remains no consensus regarding which classes of agents to add as dual and triple therapy, if and when required [9][10][11]23]. Clinical trials have reported safety and efficacy of teneligliptin as DPP-4 inhibitors [24,25].…”

“…According to one meta-analysis, there was 50% chance of hypoglycemic symptoms when DPP-4 inhibitor was added to sulfonylurea, compared with placebo added to a sulfonylurea [33]. As per one meta-analysis of teneligliptin, the use of second-line therapy used with caution due to the risk of hypoglycemia, weight gain, and lower durability of glycemic response [24]. The selection of antidiabetic medications for combination therapy depends on the patient's characteristics, efficacy of initial medicine, and cardiovascular benefit [33].…”