The aim of the ongoing CANDLE trial is to test the safety and nonâinferiority of ... amelioration of the clinical course of T2DM patients with ...... matsuzaki_h.pdf.
Tanaka et al. Cardiovasc Diabetol (2016) 15:57 DOI 10.1186/s12933-016-0381-x
Cardiovascular Diabetology Open Access
STUDY PROTOCOL
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 Atsushi Tanaka1, Teruo Inoue2, Masafumi Kitakaze3, Jun‑ichi Oyama4, Masataka Sata5, Isao Taguchi6, Wataru Shimizu7, Hirotaka Watada8, Hirofumi Tomiyama9, Junya Ako10, Yasushi Sakata11, Toshihisa Anzai12, Masaaki Uematsu13, Makoto Suzuki14, Kazuo Eguchi15, Akira Yamashina9, Yoshihiko Saito16, Yasunori Sato17, Shinichiro Ueda18, Toyoaki Murohara19 and Koichi Node1*
Abstract Background: Because type 2 diabetes mellitus is associated strongly with an increased risk of cardiovascular dis‑ eases, 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 cana‑ gliflozin, 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 cen‑ trally into either canagliflozin or glimepiride groups (1: 1) using the dynamic allocation method stratified by age (
