The Influence of Sitagliptin on Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus Receiving Insulin Treatment: A Prespecified Sub-Analysis

Abstract

IntroductionTreatment-related quality of life (QOL) is an important aspect of diabetes management. Here, we investigated the influence of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on treatment-related QOL in patients with type 2 diabetes mellitus treated with insulin.MethodsThis was a prespecified sub-analysis of the Sitagliptin Preventive Study of Intima-Media Thickness Evaluation (SPIKE). The study population consisted of 71 subjects in the sitagliptin group, and 62 subjects in the conventional group who were treated with insulin. Patients of the sitagliptin group were started on sitagliptin in addition to ongoing insulin therapy. In the conventional group, either increasing the dose of current insulin therapy or the addition of oral hypoglycemic agents other than dipeptidyl peptidase-4 inhibitors was allowed to achieve glycemic control. Treatment-related QOL was evaluated before and 104 weeks after the initiation of the study using the Diabetes Therapy-Related QOL Questionnaire 7 (DTR-QOL7).ResultsForty-five out of 71 subjects in the sitagliptin group and 41 out of 62 subjects in the conventional group filled out the QOL questionnaire at week 104. The DTR-QOL7 score at week 104 was significantly increased from baseline in the sitagliptin group, while that in the conventional group was not changed. However, the changes in score did not differ between the two groups. Change in HbA1c was negatively associated with change in score.ConclusionsOur data suggest that sitagliptin added to insulin treatment was comparable to other treatments in terms of its impact on treatment-related QOL.Clinical Trial RegistrationClinicalTrials.gov identifier: UMIN000007396.FundingMitsubishi Tanabe Pharma Co., Ono Pharmaceutical Co., and Novo Nordisk.

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.…”

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][34][35], dipeptidyl peptidase-4 inhibitors [36][37][38], and the SGLT2i ipragliflozin [39]. As in the current trial, the questionnaire has shown a high sensitivity for detecting and measuring diabetesrelated HRQoL compared with, for example, the EQ-5D questionnaire [40].…”

The Influence of Tofogliflozin on Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus

“…The scales of Q5, Q6, and Q7 were reversed so that 7 represented the highest QOL score. The DTR-QOL7 was developed because of practical constraints, using data obtained from subjects with T2DM but without apparent history of CVD [ 24 ]. Although the method of selecting seven questions from the original 29 items was not based on a technical or statistical rationale, we previously confirmed that all six items other than Q2 appeared to be included in the same domain, which suggested that the structure of the DTR-QOL7 was relatively consistent [ 24 ].…”

“…The total score, after simple addition of the item scores except the Q2 score, was converted to 0–100 (best-case response = 100; worst-case response = 0). This total score had a high internal consistency based on Cronbach’s alpha coefficients, and they were highly associated with the total scores of the original 29 items [ 24 ]. The Q2 score, which reflected weight gain with treatment, was separately evaluated.…”

“…The protocol was approved by the Osaka University Clinical Research Review Committee (IRB15000038, approval number 14386, date of approval 23 The DTR-QOL developed by Ishii is a reliable and valid questionnaire, which is a 29-item, self-administered assessment with four primary factors, presented in Japanese [20]. In the current study, we used the DTR-QOL7, a short version of the original DTR-QOL, which consisted of seven questions selected from original 29 items [24]. The items included are shown in Table 1.…”