Randomized Multicenter Evaluation of Quality of Life and Treatment Satisfaction in Type 2 Diabetes Patients Receiving Once-Weekly Trelagliptin Versus a Daily Dipeptidyl Peptidase-4 Inhibitor

Abstract

Introduction Dipeptidyl 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. Methods In 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. Results The 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. Conclusions Once-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 Registration ClinicalTrials.gov (NCT03014479) and JAPIC (JapicCTI-173482). Funding Takeda Pharmaceutical Company Ltd. Electronic Supplementary Material The online version of this article (10.1007/s13300-019-0643-1) contains supplementary material, which is available to authorized users.

Quality-of-Life Comparison of Dapagliflozin Versus Dipeptidyl Peptidase 4 Inhibitors in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (J-BOND Study)

“…DTR-QOL is a diabetes-specific QOL questionnaire [25]. Previous studies have demonstrated that both SGLT2is [29,30] and DPP4is [31,32] improve scores in DTR-QOL. The results of this study showing a significant improvement in DTR-QOL scores in both groups were consistent with the findings of previous reports.…”

Decreasing patient-reported burden of treatment: A systematic review of quantitative interventional studies

“…The burden of treatment scales used to evaluate the efficacy of the intervention were a general purpose scale (MTBQ) in one article [ 38 ], and disease-specific scales in ten studies: two used the Cystic Fibrosis Questionnaire-Revised (CFQ-R) [ 39 , 40 ], two used the Treatment-Related Impact Measures for Diabetes (TRIM-D) [ 36 , 41 ], two used the Diabetes Medication Satisfaction questionnaire (DiabMedSat) [ 35 , 42 ], one used the Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire [ 37 ], and two used ad hoc questions [ 43 , 44 ]. For some scales, a higher value corresponded to a higher burden, whereas for others, it was the opposite.…”

“…Among the seven studies that investigated a drug-based intervention, four assessed whether an intervention decreasing dosing frequency could have a lesser impact on patients’ lives [ 36 , 37 , 39 , 42 ]. Significant positive results were found in three studies, two of which were conducted in diabetic patients.…”

“…Several types of interventions were evaluated in these eleven articles (Table 2): change in medication (7 studies), change in medical devices (2 studies), and change in the care process (2 studies). Three articles [35][36][37] assessed the burden of treatment as a primary endpoint, and eight as a secondary endpoint (Tables 2 and 3). Six out of the eleven studies were focused on diabetes, including the three studies that assessed the burden of treatment as a primary endpoint.…”

Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type 2 Diabetes: The PIONEER 10 Randomized, Active-Controlled Trial

“…The DTR-QoL is a Japanese-specific measure of HRQoL that has been extensively employed in studies of glucose-lowering medication, including several involving GLP-1RAs [ 33 – 35 ], dipeptidyl peptidase-4 inhibitors [ 36 – 38 ], and the SGLT2i ipragliflozin [ 39 ]. As in the current trial, the questionnaire has shown a high sensitivity for detecting and measuring diabetes-related HRQoL compared with, for example, the EQ-5D questionnaire [ 40 ].…”