NCT07288749

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

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.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,484 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• Chronic Heart Failure (CHF)

Interventions

Type	Name	Description
DRUG	Glimepiride (oral)	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	Placebo	Standardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral placebo (equivalent placebo administered according to the same regimen)

Timeline

• Start date: 2026-01-01
• Primary completion: 2030-12-31
• Completion: 2031-12-31
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: China