Abstract | INTRODUCTION: METHODS AND ANALYSIS: A total of 190 patients with T2DM and HFpEF (ejection fraction >45%) who are drug-naïve or taking any anti-diabetic agents will be randomised (1:1) to receive luseogliflozin 2.5 mg one time per day or voglibose 0.2 mg three times per day. The patients will be stratified by age (<65 years, ≥65 years), baseline haemoglobin A1c (<8.0%, ≥8.0%), baseline BNP (<100 pg/mL, ≥100 pg/mL), baseline renal function (estimated glomerular filtration rate ≥60 mL/min/1.73 m2, <60 mL/min/1.73 m2), use of thiazolidine or not and presence or absence of atrial fibrillation and flutter at screening. After randomisation, participants will receive the study drug for 12 weeks in addition to their background therapy. The primary endpoint is the proportional change in baseline BNP after 12 weeks of treatment. The key secondary endpoints are the change from baseline in the ratio of early mitral inflow velocity to mitral annular early diastolic velocity, body weight and glycaemic control after 12 weeks of treatment. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee and the patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: UMIN000018395.
|
Authors | Kentaro Ejiri, Toru Miyoshi, Kazufumi Nakamura, Satoru Sakuragi, Mitsuru Munemasa, Seiji Namba, Atsushi Takaishi, Hiroshi Ito |
Journal | BMJ open
(BMJ Open)
Vol. 9
Issue 3
Pg. e026590
(03 30 2019)
ISSN: 2044-6055 [Electronic] England |
PMID | 30928954
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Copyright | © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
Chemical References |
- Glycoside Hydrolase Inhibitors
- Natriuretic Peptide, Brain
- Inositol
- Sorbitol
- 1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol
- voglibose
|
Topics |
- Aged
- Diabetes Mellitus, Type 2
(complications)
- Female
- Glycoside Hydrolase Inhibitors
(therapeutic use)
- Heart Failure
(drug therapy, metabolism)
- Humans
- Inositol
(analogs & derivatives, therapeutic use)
- Male
- Middle Aged
- Natriuretic Peptide, Brain
(metabolism)
- Prospective Studies
- Sorbitol
(analogs & derivatives, therapeutic use)
- Stroke Volume
|