Rationale and design of a randomized trial to test the safety and non‑inferiority of canagliflozin in patients with diabetes with chronic heart failure : the CANDLE trial

Background: Because type 2 diabetes mellitus is associated strongly with an increased risk of cardiovascular diseases, the number of patients with diabetes with chronic heart failure is increasing steadily. However, clinical evidence of therapeutic strategies in such patients is still lacking. A recent randomized, placebo-controlled trial in patients with type 2 diabetes with high cardiovascular risk demonstrated that the SGLT2 inhibitor, empagliflozin, reduced the incidence of hospitalization for heart failure. Because SGLT2 inhibitors cause a reduction in body weight and blood pressure in addition to improving glycemic control, they have the potential to exert beneficial effects on the clinical pathophysiology of heart failure. The aim of the ongoing CANDLE trial is to test the safety and non-inferiority of canagliflozin, another SGLT2 inhibitor, compared with glimepiride, a sulfonylurea agent, in patients with type 2 diabetes mellitus and chronic heart failure. Methods: A total of 250 patients with type 2 diabetes who are drug-naïve or taking any anti-diabetic agents and suffering from chronic heart failure with a New York Heart Association classification I to III will be randomized centrally into either canagliflozin or glimepiride groups (1: 1) using the dynamic allocation method stratified by age (<65, ≥65 year), HbA1c level (<6.5, ≥6.5 %), and left ventricular ejection fraction (<40, ≥40 %). After randomization, all the participants will be given the add-on study drug for 24 weeks in addition to their background therapy. The primary endpoint is the percentage change from baseline in NT-proBNP after 24 weeks of treatment. The key secondary endpoints after 24 weeks of treatment are the change from baseline in glycemic control, blood pressure, body weight, lipid profile, quality of life score related to heart failure, and cardiac and renal function. Discussion: The CANDLE trial is the first to assess the safety and non-inferiority of canagliflozin in comparison with glimepiride in patients with type 2 diabetes with chronic heart failure. This trial has the potential to evaluate the clinical safety and efficacy of canagliflozin on heart failure

Research Promotion in Nursing, Physiotherapy, Occupational Therapy and Medical Engineering - Appeal and Recommendation to the Colleague -

[Summary] Despite of the severe situations of insufficient money, labor, time, and communication, we want to promote the research activity in our university to the level of major institutions. The first step we propose is to acquire the external research grants from public resources. The specific proposal is described in grant application to increase the probability of successful adoption of the grant from the Ministry of Education and Science of Japan

Research Activities in the Department of Physical Therapy

[Introduction] It is already fifty years since the Japanese law of physical therapists and occupational therapists has been effective. The physical therapist is referred by the law as "the professionals who implements the physical therapy to persons with disabilities under the prescription of medical doctors". In fifty years, however, the target of physical therapy has been significantly expanded. The subject for physical therapy now includes the patients in acute disease just after the surgical operation in addition to those in rehabilitation stage. In other words, the physical therapy is now recognized as the indispensable intervention to the subject with acute as well as chronic disorders. On the other hand, due to a rapid transition of the society into the aged society, prevention of diseases, and decline of activity capacity due to the aging have become major issues for the physical therapy