Efficacy of high-dose teneligliptin, a dipeptidyl peptidase-4 inhibitor, for glycemic parameters in patients with type 2 diabetes estimated with continuous glucose monitoring: A pilot study

Abe, Ichiro; Sugimoto, Keiko; Takeshita, Kaori; Minezaki, Midori; Fujimura, Yoshikazu; Koga, Monami; Kuramoto, Saori; Kudo, Tadachika; Kobayashi, Kazuo

doi:10.15761/iod.1000176

Cited by 4 publications

(4 citation statements)

References 16 publications

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“…Postprandial glucose excursions, 24-h mean glucose values, and fasting plasma glucose levels were all significantly reduced with teneligliptin compared with placebo. A recent pilot study using continuous glucose monitoring to compare the effects of teneligliptin 20 and 40 mg doses in hospitalized patients with type 2 diabetes observed a significant dose-dependent reduction in the mean amplitude of glycemic excursions and maximum glucose levels [ 23 ]. High-dose teneligliptin also significantly increased minimum glucose concentrations compared with the standard dose, suggesting that teneligliptin 40 mg may provide better “quality” glucose control by reducing the risk of hypoglycemia, and may suppress diabetic complications arising from micro- and macroangiopathies [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

“…Although our previous study observed similar efficacy with 10, 20, and 40 mg doses [ 21 ], a dose-dependent reduction in HbA1c was observed over 24 weeks with teneligliptin 5–40 mg added to metformin therapy [ 22 ]. More recently, teneligliptin 40 mg was shown to reduce the mean amplitude of glycemic excursions and to increase minimum glucose concentrations compared with teneligliptin 20 mg in hospitalized patients with type 2 diabetes, suggesting that the higher dose may provide better “quality” glucose control by reducing the risk of a hypoglycemia event [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Teneligliptin 40 mg in Type 2 Diabetes: A Pooled Analysis of Two Phase III Clinical Studies

et al. 2018

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IntroductionTeneligliptin, an antihyperglycemic agent belonging to the dipeptidyl peptidase-4 inhibitor class, is usually prescribed at a dose of 20 mg/day. In Japan, the dose can be increased to 40 mg/day if needed. We examined the treatment response when the teneligliptin dose was increased from 20 to 40 mg in a post hoc pooled analysis of data from two 52-week, open-label, phase III clinical trials of teneligliptin 20–40 mg/day as monotherapy or combination treatment in Japanese patients with type 2 diabetes.MethodsIn both studies, patients received teneligliptin 20 mg for at least 28 weeks; thereafter the dose was increased if glycemic control was inadequate. The data set for this post hoc analysis comprised those patients whose teneligliptin dose was increased to 40 mg at week 28 (N = 204). We assessed (i) the proportion of patients achieving HbA1c reduction after teneligliptin dose increase [≤ − 0.1% change in HbA1c during weeks 28–52 (24 weeks); responders] and (ii) the response to teneligliptin 40 mg according to whether or not patients experienced HbA1c re-elevation (≥ 0.1% increase) during 28 weeks of teneligliptin 20 mg.ResultsOf 204 patients, 108 (52.9%) showed a response to teneligliptin 40 mg (HbA1c change ≤ − 0.1% during weeks 28–52) and had mean (± SD) HbA1c reduction of 0.50 ± 0.44%. Of patients showing re-elevation of HbA1c during treatment with teneligliptin 20 mg, 89/143 (62.2%) achieved HbA1c reduction after dose increase to 40 mg. Logistic regression analyses suggested that change in body weight is one of the parameters linked to HbA1c reduction after dose increase to teneligliptin 40 mg. The incidence of adverse events was not changed after teneligliptin dose increase.ConclusionIncreasing the dosage of teneligliptin from 20 to 40 mg/day has potential as a well-tolerated and effective option for treating type 2 diabetes.FundingMitsubishi Tanabe Pharma Corporation.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0372-x) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Teneligliptin 40 mg in Type 2 Diabetes: A Pooled Analysis of Two Phase III Clinical Studies

et al. 2018

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“…Compared with effects of standard-dose Teneligliptin, MAGE, SD, and maximum glucose concentrations were significantly reduced by high-dose Teneligliptin (p < 0.01) but there was no significant difference in mean glucose concentrations (p = 0.0314). 5 • Mean postprandial blood glucose when Teneligliptin 20 mg was increased to 40 mg was 201.5 ± 65.5 mg/dL. • Mean HbA1C when Teneligliptin 20 mg was increased to 40 mg was 8.1 ± 1.5%.…”

Section: Methodsmentioning

confidence: 98%

Study of the Efficacy of Uptitrating Teneligliptin Dose from Standard Dose (20 mg) to High Dose (40 mg) in Patients with Type II Diabetes Mellitus

Panikar

Joshi

Tiwaskar

et al. 2022

JAPI

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Aim: To study the efficacy of uptitrating the dose of Teneligliptin from 20 to 40 mg in patients with type II diabetes mellitus. Method: A retrospective, comparative analysis was undertaken in 853 type II diabetes mellitus patients (499 males and 354 females) who had follow-up records for more than 6 months. These patients were uncontrolled after use of atleast three oral antidiabetic drugs (OADs) and Teneligliptin 20 mg was added as the fourth drug. Patients who remained uncontrolled with the addition of 20 mg of Teneligliptin at the end of 3 months and were switched to receive 40 mg of Teneligliptin daily were included in this study. Results were analyzed at 3 and 6 months to ascertain efficacy of high-dose (40 mg) Teneligliptin. All other OADs remained the same in both groups. In all patients, the fasting blood glucose, postprandial blood glucose, and hemoglobin A1c (HbA1C) were evaluated and compared. Result: A total of 853 patients whose dose of Teneligliptin was increased from 20 to 40 mg were included in the study. At the end of 3 months after using Teneligliptin 40 mg, mean reduction in HbA1C was 0.5% (p-value 0.154). Similarly, mean reduction in fasting blood sugar (FBS) and postprandial blood sugar (PPBS) was 6.5 and 3.6 mg/dL, respectively (p-value 0.234 and 0.143). At the end of 6 months after using Teneligliptin 40 mg HbA1C showed no change but mean FBS and PPBS showed a modest reduction of 14.6 and 14 mg/dL, respectively (p-value < 0.001). Conclusion: The results of our study show that there was no statistically significant improvement in glycemic parameters when dose of Teneligliptin was increased from 20 to 40 mg at 3 months. But at 6 months, the FBS and PPBS showed a modest reduction of 14.6 and 14 mg/dL, respectively (p-value < 0.001) but the HbA1C showed no change.

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“…A previous study showed a statistically non-significant difference in results on HbA1c levels mediated by the standard dose (−0.9% vs. placebo) and a high dose of teneligliptin (−1.0% vs. placebo) [16]. A high dose of teneligliptin exerts proper glycemic control in DM patients [17]; it also takes part in the improvement of insulin resistance [18][19].…”

Section: Introductionmentioning

confidence: 98%

Evaluation of the Safety and Efficacy of Teneligliptin at a Higher Dose in Indian Type 2 Diabetes Patients: A Retrospective Analysis

Mitra

Ray²

2020

Cureus

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Background and aim While diabetes mellitus (DM) is occupying the topmost global epidemic position, India is harboring a challenging number of type 2 DM patients in the world. This devastating picture of the health sector in India requires the availability of more cost-effective, context-specific, and safer drugs for DM management. This study aimed to evaluate the safety and efficacy of teneligliptin in Indian patients with type 2 DM inadequately controlled with diet, exercise, and a maximal dose of metformin treatment. Materials and methods This was a retrospective, observational, and single-center study conducted at a diabetic clinic in India in type 2 DM patients who have been treated with teneligliptin 40 mg once daily as add-on therapy with diet, exercise, and the maximal tolerable dose of metformin for three months. The study was observational, where the data collection was through self-reporting and an observational study conducted over one year (September 2018 to August 2019). A total of 100 patients were enrolled in the study (male 69% and female 31%). Patients with available data for fasting plasma glucose (FPG), postprandial plasma glucose (2h PPG), glycated hemoglobin (HbA1c), renal function parameters, such as urinary albumin to creatinine ratio (UACR), and electrocardiogram (ECG) at baseline and three months after treatment were enrolled in the study. Results There was a significant reduction in fasting blood sugar (P=<0.001), postprandial blood sugar (P=<0.001), and HbA1c (P=<0.001) at the end of the three months treatment in comparison to the baseline level and in the primary outcomes of this study as compared to baseline. The teneligliptin treatment did not cause any significant reduction in body mass index (BMI) before and after treatment. When we compared the secondary outcomes, the indicator of renal function as expressed through the albumin-to-creatinine ratio (ACR; P=0.052), there was a borderline change in ACR from baseline to three months. The mean corrected QT interval at screening baseline was 429.7 ± 8.89 milliseconds while after three months, it was 429.1 ± 8.68 milliseconds, which was statistically insignificant. Conclusion The current results demonstrated a high level of efficacy as an add-on therapy of teneligliptin 1 2

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Efficacy of high-dose teneligliptin, a dipeptidyl peptidase-4 inhibitor, for glycemic parameters in patients with type 2 diabetes estimated with continuous glucose monitoring: A pilot study

Cited by 4 publications

References 16 publications

Efficacy and Safety of Teneligliptin 40 mg in Type 2 Diabetes: A Pooled Analysis of Two Phase III Clinical Studies

Efficacy and Safety of Teneligliptin 40 mg in Type 2 Diabetes: A Pooled Analysis of Two Phase III Clinical Studies

Study of the Efficacy of Uptitrating Teneligliptin Dose from Standard Dose (20 mg) to High Dose (40 mg) in Patients with Type II Diabetes Mellitus

Evaluation of the Safety and Efficacy of Teneligliptin at a Higher Dose in Indian Type 2 Diabetes Patients: A Retrospective Analysis

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