Efficacy and safety of teneligliptin added to canagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, placebo-controlled, parallel-group comparative study

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

Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes

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

Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period

<p><b>Objective</b>: To assess the efficacy and safety of teneligliptin as add-on to insulin monotherapy in patients with type 2 diabetes mellitus (T2DM).</p> <p><b>Research design and methods</b>: In a 16-week, double-blind period, 148 Japanese T2DM patients with inadequate glycemic control with insulin and diet/exercise therapies were randomized to placebo or teneligliptin 20 mg. In a subsequent 36-week, open-label period, all patients received teneligliptin once daily. The primary outcome measure was change in HbA1c at the end of the double-blind period.</p> <p><b>Results</b>: The difference between placebo and teneligliptin in change in HbA1c in the double-blind period (least squares mean ± SE) was −0.80% ± 0.11%; teneligliptin was superior (ANCOVA, <i>P</i> < 0.001). The HbA1c-lowering effect of teneligliptin was maintained throughout the open-label period. The incidence of adverse events was 53.5% with placebo and 44.2% with teneligliptin in the double-blind period, 66.7% in the placebo/teneligliptin group in the open-label period, and 77.9% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. The incidence of hypoglycemic symptoms was 11.1% in the placebo/teneligliptin group in the open-label period and 27.3% in the teneligliptin/teneligliptin group over both double-blind/open-label periods.</p> <p><b>Conclusion</b>: Teneligliptin was effective and well tolerated in Japanese T2DM patients with inadequate glycemic control.</p> <p><b>Clinical trial registration:</b> NCT02081599</p

Health and physical education class for new curriculum standards : The collaborative class with a school nurse "life saving with AED"

新中学校学習指導要領が2008年3月に告示された。保健の内容において, ｢応急手当には, 心肺蘇生等があること｣という文言が加えられた。また, 今回の授業実施後に発表された高等学校指導要領改訂案(保健)においても, ｢心肺蘇生法等の応急手当は, 傷害や疾病によって身体が時間の経過とともに損なわれていく場合があることから, 速やかに行う必要があること｣の文言が盛り込まれた。これらは, 2006年の｢救急蘇生法の指針｣の改訂の中でAEDの使用が応急手当の手順に加えられたことやそのことに連動して心臓マッサージが一層重視されるようになったという動向を受けたものである。大阪ライフサポート協会は, ｢救急蘇生の最終目標は, 突然緊急事態に際した人の命を救い, 健康で後遺症に悩まされることのない幸せな人生を確保することである。そして, 救急蘇生の原点は, 倒れた人・急変した人に向かって勇気をもって第一歩を踏み出すことである。｣と, 多くの人が心肺蘇生法を理解し実施できるようになることの必要性を説いている。このような情勢を受け, 生徒たちに対して, いざという場面に出会ったとき, 勇気をもって対処できるような力を育みたいと考え, そのための授業のあり方を検証することとした