Tests glimepiride in people with type 2 diabetes and heart failure

Trial details

Who runs it

Tongji Hospital

Trial code

NCT07288749

Record updated

17 December 2025

Original description

Evaluating the safety and efficacy of glimepiride in patients with type 2 diabetes and chronic heart failure with reduced ejection fraction--a multicenter randomized controlled study.Read full original descriptionShow less

Efficacy Evaluation of Glimepiride in Patients With Type 2 Diabetes Mellitus and Chronic Heart Failure With Reduced Ejection Fraction: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial.

Evaluating the safety and efficacy of glimepiride in patients with type 2 diabetes and chronic heart failure with reduced ejection fraction--a multicenter randomized controlled study.

Inclusion: Age between 18 and 80 years old at the time of enrollment; gender is not restricted; Patients diagnosed with type 2 diabetes according to the "Chinese Diabetes Prevention and Management Guidelines (2024 Edition)" issued by the Chinese Medical Association Diabetes Branch, with a confirmed diagnosis at least three months prior; According to the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (2024 Edition)" issued by the Chinese Society of Cardiology, the diagnosis is heart failure with reduced ejection fraction (HFrEF) or heart failure with mildly reduced ejection fraction (HFmrEF), confirmed at least three months prior; NYHA heart failure classification stage II-IV; Within 12 months prior to enrollment, left ventricular ejection fraction (LVEF) was < 50%, as determined by echocardiography, nuclear ventriculography, angiography, or cardiac magnetic resonance imaging; NT-proBNP levels ≥ 600 pg/mL in patients with no recent hospitalization for heart failure; NT-proBNP levels ≥ 400 pg/mL within the past 12 months due to heart failure hospitalization; NT-proBNP levels ≥ 900 pg/mL in patients with heart failure complicated by atrial fibrillation/flutter; Patients must have experienced stable heart failure symptoms for at least three months prior to enrollment and must have received standardized chronic heart failure therapy and guideline-directed diabetes management for no less than two weeks before enrollment, with no dose adjustments during this period; Participation is voluntary and requires signing an informed consent form; follow-up can extend beyond three years.

Exclusion: Currently experiencing acute decompensated heart failure (ADHF) or hospitalized for ADHF within the previous four weeks before enrollment; Patients scheduled to undergo coronary artery revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or cardiac resynchronization therapy following randomization, or who have received cardiac resynchronization therapy within 12 weeks prior to enrollment; Received glimepiride treatment within 8 weeks prior to enrollment or previously demonstrated intolerance to glimepiride; Heart failure caused by valvular disease, congenital heart conditions, pericardial diseases, arrhythmias, or non-cardiogenic illnesses; as well as heart failure resulting from failure of vital organs such as renal or hepatic failure; and right-sided heart failure due to pulmonary origin or other definitive causes; Cardiac shock, uncontrollable malignant arrhythmias, second-degree or higher sinus or atrioventricular block without pacemaker therapy, progressive unstable angina pectoris, or acute myocardial infarction; Uncontrolled hypertension with systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg; or SBP <90 mmHg and/or DBP <60 mmHg; Patients with a history of allergies or hypersensitivity to glimepiride or its derivatives; Conditions where the investigator deems the patient unable to understand and/or comply with study medications, procedures, or any other circumstances that may prevent completion of the study; Any conditions other than cardiovascular diseases, including but not limited to malignancies with an expected survival of less than three years, severe mental disorders, hematologic diseases, neuroendocrine disorders, elevated liver transaminases and alkaline phosphatase levels exceeding three times the upper limit of normal (ULN), renal impairment indicated by serum creatinine greater than 2 mg/dL (176.82 µmol/L), and hyperkalemia with serum potassium levels exceeding 5.5 mmol/L; Chronic kidney disease stage 3b or more advanced renal impairment (i.e., estimated glomerular filtration rate [eGFR]/creatinine clearance [CrCl] <45 ml/min); Left ventricular outflow tract obstruction, acute or fulminant myocarditis, aortic aneurysm, aortic dissection, or significant hemodynamic changes caused by unrepaired valves; Female patients who are pregnant, planning to become pregnant, or breastfeeding; Patients who have participated in any other investigational medicinal product clinical trial within the past 4 weeks; Patients refusing to comply with study requirements to complete the research; Any other reason deemed inappropriate for inclusion by the study physician.

ClinicalTrials.gov NCT07288749