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Dipeptidyl peptidase‐4 (DPP‐4) inhibitors and sodium glucose co‐transporter 2 (SGLT2) inhibitors are frequently used in combination for the treatment of type 2 diabetes mellitus (T2DM). We examined the efficacy and safety of teneligliptin (a DPP‐4 inhibitor) added to canagliflozin (an SGLT2 inhibitor) monotherapy in Japanese patients with poorly controlled T2DM as part of the development of a fixed‐dose combination of teneligliptin and canagliflozin. Japanese patients treated with canagliflozin (100 mg) for ≥12 weeks were randomized to receive add‐on teneligliptin (20 mg; C + T group) or placebo (C + P group) for 24 weeks. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to Week 24. The between‐group differences in reductions from baseline to Week 24 were significantly greater in the C + T group for HbA1c (−0.94%; P < .001). The incidence of adverse events was similar in both groups (55.8% and 49.4% in the C + T and C + P groups, respectively). No episodes of hypoglycaemia were reported. Teneligliptin added to ongoing canagliflozin monotherapy improved glycaemic control and was well tolerated in Japanese patients with inadequately controlled T2DM.

Aim: To evaluate the long‐term safety and efficacy of canagliflozin as add‐on therapy in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control with teneligliptin monotherapy. Methods: This open‐label 52‐week study was conducted in Japan. Patients received canagliflozin 100 mg added to teneligliptin 20 mg orally once daily for 52 weeks. The safety endpoint was the incidence of adverse events (AEs). The efficacy endpoints included changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and body weight from baseline to week 52 (with last observation carried forward). Results: Overall, 153 patients entered the treatment period and 142 completed the study. The overall incidence rates of AEs and drug‐related AEs were 69.9% and 22.9%, respectively. Most AEs and drug‐related AEs were mild or moderate in severity. There were no previously undescribed safety signals. The mean changes in HbA1c, FPG and body weight were −0.99% (95% confidence interval [CI] −1.12 to −0.85), −38.6 mg/dL (95% CI −43.4 to −33.9) and −3.92% (95% CI −4.53 to −3.31), respectively. These effects were maintained for 52 weeks without attenuation. HbA1c and body weight were both decreased in 82.24% of patients at the end of the treatment period. Reductions in postprandial glucose were observed at weeks 24 and 52. Conclusions: No new safety risks with this combination were identified, and sustained improvements in HbA1c, FPG and body weight were observed. The findings suggest that long‐term co‐administration of canagliflozin with teneligliptin is well tolerated and effective in Japanese patients with T2DM who have inadequate glycaemic control on teneligliptin alone.

Maki Gouda,1 Miyuki Matsukawa,2 Hiroaki Iijima3 1Medical Intelligence Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan; 2Data Science Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan; 3Medical Affairs Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan Purpose: To investigate the impact of poor eating habits on glycemic and metabolic control, we analyzed the associations between eating behaviors and HbA1c and body mass index (BMI) in Japanese workers with type 2 diabetes mellitus (T2DM). Subjects and methods: The Japan Medical Data Center database of workers’ medical health insurance claims was used to identify individuals with T2DM who were receiving antidiabetic medication between April 2012 and March 2015 (the primary analysis population). The database included routine medical check-up results and responses to questions on lifestyle and eating habits. Using these, we retrospectively analyzed the associations between the individuals’ eating habits and their HbA1c levels and BMIs. Results: In total, 31,722 individuals were included in the primary analysis. The mean values of HbA1c and BMI were 7.27% and 26.29 kg/m2, respectively; these tended to be higher among the younger population. Approximately 36% of the individuals regularly ate supper within 2 hours of bedtime, 14.5% regularly consumed late-night snacks, and 13.4% regularly skipped breakfast. Each of these eating habits correlated significantly with higher HbA1c and BMI. In addition, the population with two or all three of these poor dietary habits showed the highest association with HbA1c ≥7.0% and BMI ≥25 kg/m2. Approximately 38% of workers ate fast. Fast eating was significantly associated with BMI ≥25 kg/m2 but not with HbA1c ≥7.0%. Conclusion: Poor eating habits were significa