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Efficacy and safety of once-weekly oral trelagliptin switched from once-daily dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus: An open-label, phase 3 exploratory study.

ABSTRACT: Trelagliptin, a novel once-weekly oral dipeptidyl peptidase-4 (DPP-4) inhibitor, has shown favorable efficacy and safety in type 2 diabetes mellitus patients. Trelagliptin was launched in Japan, and is expected to be initially used for switchover from a daily DPP-4 inhibitor in the clinical setting. Thus, the present study was carried out to explore the efficacy and safety of trelagliptin after a daily DPP-4 inhibitor was switched to it.This was an open-label, phase 3 exploratory study to evaluate the efficacy and safety of trelagliptin in Japanese type 2 diabetes mellitus patients who had stable glycemic control on once-daily sitagliptin therapy. Eligible patients received trelagliptin 100 mg orally before breakfast once a week for 12 weeks. The primary end-point was blood glucose by the meal tolerance test, and additional end-points were glycemic control (efficacy) and safety.Altogether, 14 patients received the study drug. The blood glucose did not markedly change from baseline at major assessment points in the meal tolerance test, and a decrease in blood glucose was observed at several other assessment points. Adverse events were reported in 42.9% (6/14) of patients, but all adverse events were mild or moderate in severity, and most were not related to the study drug. No cases of death, serious adverse events or hypoglycemia were reported.It is considered possible to switch a once-daily DPP-4 inhibitor to trelagliptin in type 2 diabetes mellitus patients with stable glycemic control in combination with diet and exercise therapy without any major influences on glycemic control or safety.

SUBMITTER: Inagaki N

PROVIDER: S-EPMC5835476 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Efficacy and safety of once-weekly oral trelagliptin switched from once-daily dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus: An open-label, phase 3 exploratory study.

Inagaki Nobuya N Sano Hiroki H Seki Yoshifumi Y Kuroda Shingo S Kaku Kohei K

Journal of diabetes investigation 20171030 2

<h4>Introduction</h4>Trelagliptin, a novel once-weekly oral dipeptidyl peptidase-4 (DPP-4) inhibitor, has shown favorable efficacy and safety in type 2 diabetes mellitus patients. Trelagliptin was launched in Japan, and is expected to be initially used for switchover from a daily DPP-4 inhibitor in the clinical setting. Thus, the present study was carried out to explore the efficacy and safety of trelagliptin after a daily DPP-4 inhibitor was switched to it.<h4>Materials and methods</h4>This was ...[more]

PMID: 28836351

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Project description:IntroductionDipeptidyl peptidase-4 (DPP-4) inhibitors are an established treatment in type 2 diabetes mellitus (T2DM). The objective of this study was to investigate differences in quality of life (QOL) and treatment satisfaction among treatment-naïve T2DM patients receiving once-weekly trelagliptin or a daily DPP-4 inhibitor.MethodsIn this multicenter, randomized, open-label, parallel-group, phase IV study conducted in Japan, 218 patients were randomized to trelagliptin 100 mg once weekly or a once- or twice-daily DPP-4 inhibitor for 12 weeks (NCT03014479; JapicCTI-173482). QOL and treatment satisfaction were assessed using the Diabetes Therapy-Related QOL (DTR-QOL) Questionnaire and Diabetes Treatment Satisfaction Questionnaire (DTSQ), respectively. The primary endpoint was change from baseline in DTR-QOL total score at week 12. Secondary endpoints included further analysis of the DTR-QOL and DTSQ components. Other endpoints included glycemic control, treatment adherence, and safety.ResultsThe between-group difference in the change from baseline to week 12 in DTR-QOL total score was 2.418 (95% confidence interval - 1.546, 6.382; P = 0.2305). Analysis of the DTR-QOL and DTSQ results by subscales and stratification generally showed a numerical improvement with trelagliptin over daily DPP-4 inhibitors. QOL and treatment satisfaction improved with a reduction in frequency of concurrent and study drug dosing. Treatment adherence was > 97% for both groups. The effect of trelagliptin on glycemic control was similar to that seen with daily DPP-4 inhibitors. Trelagliptin and daily DPP-4 inhibitors were well-tolerated and demonstrated similar safety profiles.ConclusionsOnce-weekly trelagliptin 100 mg administered for 12 weeks resulted in a numerically, but not statistically, greater improvement in QOL and treatment satisfaction versus daily DPP-4 inhibitors. The decision to administer once-weekly or daily DPP-4 inhibitor treatment is likely to depend on patient preferences and the treatment policies of physicians.Trial registrationClinicalTrials.gov (NCT03014479) and JAPIC (JapicCTI-173482).FundingTakeda Pharmaceutical Company Ltd.

Project description:Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease with substantial morbidity, mortality, and economic impacts. Glucagon-like peptide-1 (GLP-1) receptor agonists, such as once-daily (QD) liraglutide and once-weekly (QW) exenatide, are FDA-approved treatment for T2DM. Head-to-head trials and meta-analyses comparing these agents have reported clinically meaningful improvements but small differences in glycemic control between both agents. In this study, we calculate and compare the cost-effectiveness implications of these alternative effectiveness outcomes.We developed a decision model to evaluate the short-term cost-effectiveness of exenatide QW 2 mg versus liraglutide QD 1.8 mg in T2DM patients, with effectiveness measured as reduction in glycated hemoglobin (HbA1c). In the base case, the model tracks change in HbA1c and direct medical expenditure over a 6-month time horizon. We calculated and compared the cost per 1% reduction in HbA1c of models populated with clinical data from a head-to-head randomized, controlled trial (DURATION-6) and a network meta-analysis. Expenditure inputs were derived from wholesale acquisition costs and published sources.In the base case, 6-month expenditure for the liraglutide and exenatide strategies were $3,509 and $2,618, respectively. Using clinical data from DURATION-6 and the network meta-analysis, the liraglutide strategy had an incremental cost per 1% reduction in HbA1c of $4,773 and $27,179, respectively. The most influential model parameters were drug costs, magnitude of HbA1c reduction in patients on treatment for >1 month, and liraglutide gastrointestinal adverse event rate. In probabilistic sensitivity analyses (PSA) using DURATION-6 data, the exenatide strategy was optimal at willingness-to-pay levels below $4,800 per 1% reduction in HbA1c. In a PSA using meta-analysis data, the exenatide strategy was dominant.Our modeled results demonstrate that the effectiveness and cost-effectiveness of liraglutide QD 1.8 mg relative to exenatide QW 2 mg depend largely on the chosen source of the clinical data.

Dataset Information

Efficacy and safety of once-weekly oral trelagliptin switched from once-daily dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus: An open-label, phase 3 exploratory study.

Publications

Efficacy and safety of once-weekly oral trelagliptin switched from once-daily dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus: An open-label, phase 3 exploratory study.

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