Efficacy Evaluation of Glimepiride in Patients With Type 2 Diabetes Mellitus and Chronic Heart Failure With Reduced Ejection Fraction.

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTongji Hospital

About this 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

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.

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.

Trial design

Treatments tested in this trial

  • Glimepiride (oral)
  • Placebo

Treatment groups

1,484 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tongji Hospital

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator

Nanjing Medical University

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Huaxi Hospital

Collaborator

Zhongnan Hospital

Collaborator

Xiangya Hospital

Collaborator

Beijing Anzhen Hospital

Collaborator

The First Affiliated Hospital of Air Force Medicial University

Collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

First Affiliated Hospital of Xinjiang Medical University

Collaborator

Anhui Provincial Hospital

Collaborator

Southwest Medical University

Collaborator

First Hospital of China Medical University

Collaborator

Wuhan Central Hospital

Collaborator

Tianjin Medical University

Collaborator