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IntroductionTo measure the burden of pharmacotherapy on patients with type 2 diabetes mellitus (T2DM), we developed the Diabetes Treatment Burden Questionnaire (DTBQ), a patient-administered questionnaire composed of 18 questions, and evaluated its reproducibility and validity.MethodsWe enrolled 240 patients with T2DM under pharmacotherapy over 20 years of age at seven institutes in Japan. Their physicians filled out report forms on patient backgrounds, and the patients answered both the DTBQ and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). For evaluation of reproducibility, 48 of the enrolled subjects completed a 2nd DTBQ at home after leaving the medical institutes.ResultsStatistical analyses were performed for two sets of subjects, the validity analysis set (N = 236) and the reproducibility analysis set (N = 47). Factor analysis found a simple structure in the DTBQ item scores using a three-factor model with varimax rotation; the three subscales were designated as “implementation burden”, “flexibility burden”, and “blood glucose control burden”. All intraclass correlation coefficients for the subscale scores were 0.8 or higher, indicating high reproducibility. Negative correlations were observed between the DTSQ satisfaction score and the DTBQ subscale scores. Moreover, as the dosing frequency of diabetic medicines increased, the DTBQ total score (total burden score) also became higher. Likewise, expected associations were observed between patient backgrounds and DTSQ scores.ConclusionThe DTBQ has adequate reproducibility and validity as a measurement scale for treatment burden on T2DM patients.Trial RegistrationUniversity Hospital Medical Information Network (UMIN) 000026382.FundingEli Lilly Japan.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0414-4) contains supplementary material, which is available to authorized users.

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IntroductionIt is unclear whether adding basal insulin or enhancing incretin signaling with a glucagon-like peptide-1 receptor agonist (GLP-1RA) is more effective as an up-titration strategy after dipeptidyl peptidase-4 inhibitor (DPP-4i)-based oral antidiabetic drug (OAD) therapy. GLP-1RAs can be injected without dose adjustment, unlike basal insulin. Our objective was to examine the efficacy of changing patients inadequately controlled with oral DPP-4i-based OAD therapy to injectable GLP-1RA and discontinuing the DPP4i versus adding basal insulin glargine (IGlar) with the continuation of the oral DPP4i.MethodsSixty patients with type 2 diabetes (T2DM) and glycated hemoglobin (HbA1c) between 7.0% and 10.0% on DPP-4i-based OAD therapy were randomized to either adding IGlar and remaining on the DPP-4i or liraglutide and discontinuing the DPP-4i for 24 weeks. Patients in the IGlar group started with 0.1 unit/kg and were titrated according to the algorithm. In the liraglutide group, the DPP-4i was replaced with liraglutide 0.9 mg/day, the maximum dose in Japan. We evaluated HbA1c, glycated albumin (GA), and anthropometrics.ResultsHbA1c was significantly lower at week 24 (− 1.0 ± 0.9% in the IGlar group and − 0.6 ± 0.8% in the liraglutide group), but the difference between groups was not significant. Changes in GA were similar (− 2.9 ± 3.2% vs. − 2.6 ± 3.2%) in both groups. Body weight (BW) was significantly lower only in the liraglutide group (+ 0.5 ± 2.6 kg vs. − 2.2 ± 2.0 kg). The rate of minor hypoglycemic episodes was similar for both groups.ConclusionFor poorly controlled T2DM on DPP-4i-based OAD therapy, switching to single-dose liraglutide to enhance incretin signaling is as effective as dose-titrated basal IGlar, but significant BW reduction was only seen in the liraglutide group. These results suggest that enhancing incretin signaling with a single-dose injectable GLP-1 RA might be an alternative to dose-titrated basal insulin therapy in patients with T2DM poorly controlled with DPP-4i-based OAD therapy. These findings should be confirmed in a longer and larger trial.Trial RegistrationTrial Registry (UMIN-CTR) as UMIN000012224.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0486-1) contains supplementary material, which is available to authorized users.