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

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Nanjing Medical University

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Huaxi Hospital

  collaborator OTHER

• Zhongnan Hospital

  collaborator OTHER

• Xiangya Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• The First Affiliated Hospital of Air Force Medicial University

  collaborator OTHER

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Southwest Medical University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Wuhan Central Hospital

  collaborator OTHER

• Tianjin Medical University

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2030-12-31

Completion

2031-12-31

Countries

• China

Study Locations