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Introduction: Consideration of treatment-related quality of life (QOL) is important in diabetes management. However, no studies have compared the influence of dipeptidyl peptidase-4 inhibitors versus metformin on treatment-related QOL when used as first-line therapy in patients with type 2 diabetes mellitus.Methods: This study is a prospective, randomized, open-label, multicenter, parallel-group, comparative study. Between June 2016 and December 2017, 44 participants who failed to achieve glycemic control despite diet and exercise therapy were recruited at 14 clinics and randomly allocated to linagliptin or metformin therapy. Treatment-related QOL was assessed with the Oral Hypoglycemic Agent Questionnaire, version 2 (OHA-Q ver. 2) and the self-administered Diabetes Therapy-Related QOL (DTR-QOL) questionnaire. The primary study outcome is the difference in total OHA-Q ver. 2 score between the two treatment groups at the end of the study. The secondary outcomes include differences in the scores for each OHA-Q ver. 2 subscale between the two treatment groups at the end of the study, change in total DTR-QOL score and for each domain from baseline to the end of treatment, changes in glycemic control, and adverse events.Planned outcome: The present study is designed to assess the effects of linagliptin on the treatment-related QOL. Results will be available in the near future. Study findings are expected to provide useful information on how to maintain or improve QOL in patients with type 2 diabetes mellitus treated with insulin.Funding: Nippon Boehringer Ingelheim Co., Ltd. and Eli Lilly and Company.Clinical trial registration: UMIN000022953. [ABSTRACT FROM AUTHOR]

Aims: To compare the efficacy on glycemic parameters between a 12-week administration of once-daily linagliptin and thrice-daily voglibose in Japanese patients with type 2 diabetes.Methods: In a multi-center, randomized, parallel-group study, 382 patients with diabetes were randomized to the linagliptin group (n=192) or the voglibose group (n=190). A meal tolerance test was performed at weeks 0 and 12. Primary outcomes were the change from baseline to week 12 in serum glucose levels at 2h during the meal tolerance test, HbA1c levels, and serum fasting glucose levels, which were compared between the 2 groups.Results: Whereas changes in serum glucose levels at 2h during the meal tolerance test did not differ between the groups, the mean change in HbA1c levels from baseline to week 12 in the linagliptin group (-0.5±0.5% [-5.1±5.4mmol/mol]) was significantly larger than in the voglibose group (-0.2±0.5% [-2.7±5.4mmol/mol]). In addition, there was significant difference in changes in serum fasting glucose levels (-0.51±0.95mmol/L in the linagliptin group vs. -0.18±0.92mmol/L in the voglibose group, P<0.001). The incidences of hypoglycemia, serious adverse events (AEs), and discontinuations due to AEs were low and similar in both groups. However, gastrointestinal AEs were significantly lower in the linagliptin group (1.05% vs. 5.85%; P=0.01).Conclusions: These data suggested that linagliptin monotherapy had a stronger glucose-lowering effect than voglibose monotherapy with respect to HbA1c and serum fasting glucose levels, but not serum glucose levels 2h after the start of the meal tolerance test. [ABSTRACT FROM AUTHOR]