Teneligliptin In Patients Research Articles

Vitamin D as add on Therapy to Metformin and Teneligliptin in patients with type 2 Diabetes Mellitus

A low level of vitamin D is being attributed to the development of diabetes, which can cause insulin resistance, beta-cell death, and inflammation. Vitamin D supplementation can reduce inflammation and insulin resistance. we conducted this study for our population to evaluate the effect of vitamin D on blood glucose in type 2 diabetes mellitus. A prospective interventional, parallel, randomized study, was conducted on 112 type two diabetes and 25(OH) D deficient patients. The control group received Metformin (500mg BD) and Teneligliptin (20mg OD) only, while the intervention group was given Metformin plus Teneligliptin along with vitamin D (Cholecalciferol) (60,000 IU). At the end of 3rd of month follow-up, there was a significant difference in mean FPG and PPG (129.86±7.36mg/dl) vs. (136.12±11.31mg/dl) (p=0.002), (220.81±13.04mg/dl) vs. (228.06±19.40 mg/dl) (p=0.037). in the interventional and control group respectively. And subsequently, mean HbA1c improved significantly in the interventional group as compared to the control group 7.21±0.40% vs. 7.48.0.62% respectively (p = 0.015). also, the measures of glycemic control (FPG, PPG, HbA1c) showed a significant improvement at the end of the 6 months. Our study suggested, that add-on therapy of Vitamin D improved the glycemic parameters of type two diabetes mellitus with concurrent vitamin D deficiency over the course of the study.

A prospective, randomised, open label study to compare efficacy and safety of hydroxychloroquine and teneligliptin in patients of type 2 diabetes mellitus refractory to concomitant metformin and glimepiride

Background: Diabetes mellitus is chronic, metabolic disease characterized by hyperglycemia, which over time causes both microvascular and macrovascular complications. If HbA1c target is not achieved with dual therapy then 3rd drug is added. Aims of present study were to compare efficacy and safety of Hydroxychloroquine (HCQ) and Teneligliptin in patients of T2DM who are refractory to concomitant Metformin and Glimepiride. Methods: It was interventional, randomized, prospective, parallel and open-label study. Patients were randomly divided into 2 groups either HCQ 400mg OD or Teneligliptin 20mg OD were added to their current treatment using Metformin 1gm BD and Glimepiride 4 mg OD as 3rd drug. Follow up was done every 15 days for 12 weeks and underwent assessment of glycaemic parameters (FBS, PPG, HbA1c), LFT, RFT, CBC, ADRs and VAS in addition to anthropometric parameters. Results: After 12 weeks of treatment, HCQ group showed statistically (p<0.05) better improvement in BMI than Teneligliptin group. Both groups showed comparable improvement (p>0.05) from baseline in FBS, HbA1c, PPG and VAS score. In HCQ group there was significant number (p<0.05) of patients who achieved target glycaemic control (HbA1c ≤7.5%) i.e., 56.6%, compared to 37% with Teneligliptin group. Both groups had comparable (p>0.05) safety profile with no serious adverse effects and no significant change (p>0.05) in hepatic, renal and complete blood profiles. Conclusions: On the basis of effects of HCQ on the glycaemic parameters and BMI, HCQ may be preferred over Teneligliptin in patients of T2DM who are refractory to concomitant Metformin and Glimepiride.

Efficacy and Safety of Switching to Teneligliptin in Patients with Type 2 Diabetes Inadequately Controlled with Dipeptidyl Peptidase-4 Inhibitors: 52-Week Results from a Prospective Observational Study.

IntroductionThe aim of this study was to assess the efficacy and safety of switching to teneligliptin from other dipeptidyl peptidase-4 (DPP-4) inhibitors in patients with type 2 diabetes mellitus (T2DM) inadequately controlled despite treatment with a stable dose of other DPP-4 inhibitors.MethodsPatients with glycosylated hemoglobin (HbA1c) ≥ 7% despite taking DPP-4 inhibitors other than teneligliptin, with or without other antidiabetic agents, for at least 3 months were enrolled in this study. Patients on DPP-4 inhibitors administered prior to participation in this study were switched to 20 mg teneligliptin once daily and the dose was maintained for the 52-week study period. The primary endpoint was the change in HbA1c at week 12. Fasting plasma glucose (FPG) and the blood lipid profile were also evaluated. Adverse events were monitored for safety assessment.ResultsAt weeks 12, 24, and 52, the HbA1c values significantly decreased by − 0.39, − 0.44, and − 0.52%, respectively, compared to the baseline value (p < 0.0001); in addition, 56.3, 60.3, and 62.3% of patients, respectively, achieved decreases in HbA1c of at least 0.3%, and 40.1, 46.5, and 52.4% of patients, respectively, achieved decreases in HbA1c of at least 0.5%. The proportion of the patient population achieving HbA1c < 7.0% increased throughout the study period, reaching 30.4, 35.4, and 36.9% at weeks 12, 24, and 52, respectively; at these same time points, the percentage of patients achieving HbA1c < 6.5% increased to 9.5, 11.9, and 13.2% of the total study population. FPG levels and lipid parameters were also significantly decreased after teneligliptin treatment. There were no significant safety concerns.ConclusionOur results suggest the significant glucose-lowering effect of teneligliptin after switching from other DPP-4 inhibitors in patients with T2DM. The improvement in glycemic control was maintained for up to 52 weeks without safety concerns.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01148-1.

Efficacy and Safety of Switching to Teneligliptin in Patients with Type 2 Diabetes Inadequately Controlled with Dipeptidyl Peptidase-4 Inhibitors: A 12-Week Interim Report.

IntroductionTeneligliptin, an antidiabetic agent classified as a class III dipeptidyl peptidase-4 (DPP-4) inhibitor, has a unique structural feature that provides strong binding to DPP-4 enzymes. We investigated the efficacy and safety of switching patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control on a stable dose of other DPP-4 inhibitors to teneligliptin.MethodsPatients with T2DM whose glycosylated hemoglobin (HbA1c) levels were ≥ 7% despite taking DPP-4 inhibitors other than teneligliptin, with or without other hypoglycemic agents, for at least 3 months were enrolled. The DPP-4 inhibitors taken before participating in the study were switched to 20 mg qd teneligliptin, and this was to be maintained for 52 weeks. The primary end point was the change in HbA1c levels after 12 weeks. Metabolic parameters including fasting plasma glucose (FPG) and blood lipids were assessed also. To assess safety, adverse and hypoglycemic events were monitored. The data from baseline to week 12 were used for analysis in this interim report.ResultsThe mean change in HbA1c levels from baseline to week 12 was − 0.44%. At week 12, the percentage of patients achieving HbA1c < 7.0% was 31.6% and that of achieving HbA1c < 6.5% was 11.4%, respectively. In 41.2% of patients, the HbA1c levels decreased by at least 0.5% at 12 weeks. The mean change in FPG levels from baseline to week 12 was − 11.5 mg/dl. No severe hypoglycemia was reported.ConclusionAfter switching to teneligliptin, HbA1c levels decreased significantly in patients with T2DM inadequately controlled with other DPP-4 inhibitors.Trial RegistrationClinicalTrials.gov, NCT03793023.FundingHandok Inc.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-019-0628-0) contains supplementary material, which is available to authorized users.

Efficacy and Safety of Teneligliptin in Patients of Type 2 Diabetes Mellitus with Chronic Kidney Disease: ATEND-CKD Study

Background: Prior studies have estimated prevalence of CKD among non-institutionalized adults with type 2 diabetes mellitus (T2DM) at 34.5–42.3%, with most CKD cases identified as early stage (stage 1 or 2). Diabetes affects many organs, and complications due to high blood glucose are an important cause of disability, reduced quality of life, and premature death. (8) There is paucity of data regarding efficacy and safety of teneligliptin in T2DM with chronic kidney disease (CKD) especially in Indian population and therefore this study was planned. Methods: This was a phase IV, multi-centric, open labelled, non-comparative, user initiated study done in 405 patients diagnosed with CKD due to uncontrolled T2DM. Patients were given samples of Teneligliptin 20 mg at initial visit at day 1 and asked to take one tablet daily for a total of 90 days. Glycemic and renal profile during initial and follow up visit was used for efficacy evaluation. Patients were instructed to keep a diary to record daily symptoms and adverse events if any for safety evaluation. Results: Teneligliptin reported significant mean reduction in FPG and PPBG by 40.4 and 57.5 mg/dl respectively. At 12 weeks, statistically significant 0.9% reduction in HbA1c was noted. Effects on renal parameters were also found significantly positive in this study, with reduction of Sr. creatinine by around 4% and reduction in the BUN of around 9%. There was decrease in mean urinary albumin and UACR and increase in mean eGFR, though it was not statistically significant. Among all the patients, 6.41% of patients experienced adverse event. Hypoglycemia was the most common adverse event seen in 4.44% of patients followed by constipation (1.23%) and gastritis (0.74%). Conclusion: The study reported significant improvement in glycaemic control, serum creatinine and BUN with teneligliptin.

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

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.

Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance.

IntroductionTeneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function.MethodsFor this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1–G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation.ResultsA total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98–6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was − 0.68 to − 0.85% and − 0.71 to − 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [− 2.29%, (p < 0.001) after 1 year; − 1.64%, (p = 0.064) after 2 years].ConclusionsDuring long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from normal to end-stage renal disease, including those on dialysis, and improved glycemic control.Trial Registration NumberJapic CTI-153047.FundingMitsubishi Tanabe Pharma Corporation and Daiichi Sankyo Co, Ltd.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0416-2) contains supplementary material, which is available to authorized users.

Efficacy and Safety of Teneligliptin in Indian Patients with Inadequately Controlled Type 2 Diabetes Mellitus: A Randomized, Double-blind Study.

Aims:This study evaluated the efficacy and safety of teneligliptin in patients with inadequately controlled type 2 diabetes mellitus (T2DM).Settings and Design:This was a randomized, doubleblind, placebocontrolled, parallelgroup, multicenter, Phase III study.Subjects and Methods:Patients with T2DM and inadequate glycemic control (glycosylated hemoglobin [HbA1c]: >7.0-≤8.5%) were enrolled. Patients were randomly assigned (ratio: 2:1) to receive teneligliptin 20 mg (Glenmark) or placebo. The primary efficacy variable was change from baseline in HbA1c at week 16. Additional analyses included the proportion of patients who achieved target of HbA1c ≤7.0%, changes in fasting plasma glucose (FPG), and postprandial glucose (PPG).Statistical Analysis:Mean change in HbA1c was analyzed using an analysis of covariance model, least square (LS) means, 95% confidence intervals (CIs), and P values were calculated.Results:Overall, 237 patients were included. Patients of the teneligliptin group showed reduced HbA1c levels (LS mean difference = −0.304% for intent-to-treat [ITT]; −0.291% for per-protocol (PP) populations) after 16 weeks of treatment, and a statistically significant difference was observed between the ITT (LS mean difference = 0.555; 95% CI: 0.176–0.934; P = 0.0043) and PP populations (LS mean difference = 0.642; 95% CI: 0.233–1.052; P = 0.0023). Target HbA1c level was achieved by a greater proportion of teneligliptin group patients (ITT, 43.4%; PP, 43.6%) than placebo group patients (ITT, 27.3%; PP, 26.6%). Reduction in FPG levels was observed in ITT (LS mean difference: 8.829; 95% CI: −4.357–22.016; P = 0.1883) and PP populations (LS mean difference: 11.710 mg/dL; 95% CI: −2.893-26.312; P = 0.1154). Reduction in PPG levels was higher in teneligliptin group than placebo group in both ITT (LS mean difference = 25.849 mg/dL; 95% CI: 7.143–44.556; P = 0.0070) and PP populations (LS mean difference = 25.683 mg/dL; 95% CI: 5.830–45.536; P = 0.0115). Overall, 44 patients (18.6%) experienced at least one adverse event. Three or more hypoglycemic events were experienced by 2.5% patients of teneligliptin group and none in placebo group.Conclusion:Treatment with once-daily teneligliptin led to statistically significant and clinically meaningful reductions in HbA1c and PPG, and was well tolerated in Indian patients with T2DM.

Improved glycemic control with teneligliptin in patients with type 2 diabetes mellitus on hemodialysis: Evaluation by continuous glucose monitoring

AimsRecent reports suggest that appropriate glycemic control without hypoglycemia could decrease mortality in patients with diabetes mellitus (DM) and end-stage renal disease (ESRD). However, an indication of oral anti-diabetic drugs is limited in this population. The aim of this study was to evaluate efficacy of teneligliptin, a novel DPP-4 inhibitor, by continuous glucose monitoring (CGM) in patients with type 2 DM (T2DM) on hemodialysis (HD). MethodsThis 4-week, open label, single arm, intervention trial included 10 diabetic patients undergoing HD and with glycated albumin (GA) level of ≥18.3%. Teneligliptin treatment was administered on days with HD sessions (HD day) and on days without HD sessions (NHD day); blood glucose values were measured by CGM. The primary endpoint was improvement of glycemic control evaluated by area under the curve (AUC). As secondary endpoints, changes in GA, HbA1c and fasting plasma glucose (FPG) were evaluated. ResultsTeneligliptin improved blood glucose AUC on both HD days (p=0.004), and NHD days (p=0.004). This was accompanied by a significant reduction in GA, HbA1c, and FPG, without severe hypoglycemia. ConclusionsTeneligliptin is one of the useful options for glycemic control in T2DM patients undergoing HD.

Efficacy of teneligliptin in patients with diabetes undergoing hemodialysis

Efficacy of teneligliptin in patients with diabetes undergoing hemodialysis