A Phase 3 interventional study of Glimepiride (oral) and Placebo in Type 2 Diabetes Mellitus (T2DM) and Chronic Heart Failure (CHF), sponsored by Tongji Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Tongji Hospital · Phase 3, Interventional, and Treatment
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.
Diabetes and heart failure share common pathophysiological mechanisms. The synergistic effects of managing both conditions, along with the potential for diabetes treatment to modulate the risk of heart failure outcomes, hold significant medical promise.Currently, the relationship between sulfonylureas，primarily including glimepiride, and heart failure outcomes remains poorly understood, with ongoing controversy regarding their cardiovascular effects in observational studies. No large-scale, randomized controlled trials have yet been conducted to validate the impact of sulfonylureas on patients with established heart failure. Our prospective cohort studies have preliminarily confirmed the cardioprotective effects of glimepiride in patients with type 2 diabetes complicated by chronic heart failure, demonstrating a favorable safety profile. Therefore, this study aims to conduct a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the therapeutic efficacy of glimepiride in patients with type 2 diabetes complicated by chronic heart failure.This study plan aims to recruit 1,484 eligible participants, who will be randomly assigned in a 1:1 ratio to either the glimepiride group or the placebo group. The total study duration is 36 months, with all participants required to complete baseline visits and outpatient follow-ups at months 1, 3, 6, 9, 12, 18, 24, 30 and 36.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 1,484 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
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Exclusion Criteria:
Standardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral glimepiride (initial oral dose is 2 mg once daily. After 4 weeks, adjust the oral dose based on glycemic control and tolerability: If glycemic control is adequate, maintain the initial oral dose. If glycemic control is inadequate, modify the oral dose to 4 mg once daily.)
Drug: Glimepiride (oral)
Standardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral placebo (equivalent placebo administered according to the same regimen)
Drug: Placebo
Standardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral glimepiride (initial oral dose is 2 mg once daily. After 4 weeks, adjust the oral dose based on glycemic control and tolerability: If glycemic control is adequate, maintain the initial oral dose. If glycemic control is inadequate, modify the oral dose to 4 mg once daily.)
Standardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral placebo (equivalent placebo administered according to the same regimen)
A composite endpoint of cardiovascular death, heart transplantation, or worsening heart failure (defined as rehospitalization for heart failure or an emergency heart failure visit requiring intravenous therapy).
The Primary Outcome is defined as a composite endpoint consisting of the time to the first occurrence of any of the following events: 1. Cardiovascular death is defined as any death due to a direct cardiovascular cause. 2. Heart transplantation is defined as receiving an allogeneic in situ heart transplant due to end-stage heart failure. The event date is defined as the date of surgery. 3. Heart failure exacerbation is defined as requiring intensive treatment due to worsening symptoms and signs of heart failure, meeting any of the following criteria: ① readmission for heart failure; ② urgent heart failure visit requiring intravenous therapy.
Time frame: 3 years
All-cause mortality rate
Death occurring during the study period for any cause. This is the most objective and unbiased endpoint. All deaths, whether cardiovascular-related or not, are included in this endpoint.
Time frame: 3 years
Cardiovascular death, heart transplantation, or readmission due to heart failure
Time to the first occurrence of any of the following events: cardiovascular death, heart transplantation, or rehospitalization for heart failure (defined as the primary endpoint).
Time frame: 3 years
Cardiovascular death, heart transplantation
Time to the first occurrence of any of the following events: cardiovascular death or heart transplantation (defined as the primary endpoint).
Time frame: 3 years
Rehospitalization due to heart failure
Time to first rehospitalization due to heart failure (defined as the primary endpoint).
Time frame: 3 years
Incidence of discontinuing treatment due to worsening heart failure
The patient or their family voluntarily decides to forgo aggressive life-sustaining treatment-including intravenous medications, mechanical ventilation, and renal replacement therapy-due to the extremely poor prognosis of heart failure, inability to tolerate treatment, or other reasons, ultimately resulting in the patient's death after treatment is discontinued.
Time frame: 3 years
Rate of successful resuscitation following cardiac arrest
An event where spontaneous circulation is successfully restored for ≥20 minutes following cardiac arrest (defined as pulseless ventricular tachycardia, ventricular fibrillation, or pulseless electrical activity) through cardiopulmonary resuscitation (including defibrillation, external chest compressions, pharmacotherapy, etc.).
Time frame: 3 years
Incidence of malignant arrhythmias
Clinically significant ventricular arrhythmias confirmed by electrocardiogram, Holter monitoring, or implantable device recordings. Typically includes: sustained ventricular tachycardia (lasting ≥30 seconds or requiring urgent termination due to hemodynamic instability); ventricular fibrillation; ventricular arrhythmias resulting in appropriate electrical therapy (applicable to patients with implantable cardioverter-defibrillators \[ICDs\] or cardiac resynchronization therapy defibrillators \[CRT-Ds\]).
Time frame: 3 years
Rate of serum NT-proBNP decrease
The relative rate of change in serum NT-proBNP levels from baseline to a predetermined study time point (e.g., 3 months, 6 months, or 12 months). Calculation formula: (Follow-up value - Baseline value) / Baseline value × 100%.
Time frame: 3 years
Changes in Kansas Cardiomyopathy Questionnaire (KCCQ) scores
The absolute change in the KCCQ overall summary score (or domain-specific scores such as physical function, symptom frequency, quality of life, and social limitations) from baseline to a predetermined study time point (e.g., 3 months, 6 months, or 12 months). Calculation Method: Follow-up score - Baseline score.
Time frame: 3 years
Changes in 6-Minute Walk Test (6MWT) Results
Change in 6-minute walk distance (6MWD) from baseline to follow-up (in meters).
Time frame: 3 years
Incidence of non-fatal myocardial infarction or non-fatal stroke
Time to the first occurrence of either a non-fatal myocardial infarction or a non-fatal stroke.
Time frame: 3 years
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Tongji Hospital