Recruiting soon

GLID-HFGlimepiride for Type 2 Diabetes and Chronic Heart Failure

What is being tested

Glimepiride (oral)

+ Placebo

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 80 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorTongji Hospital

Study ContactDao Wen WangMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial aims to explore the effectiveness of a diabetes medicine called glimepiride in people who have both type 2 diabetes and a type of heart failure known as chronic heart failure with reduced ejection fraction. These two health conditions often occur together and affect each other in complex ways. The study seeks to understand if glimepiride can help manage heart health in these patients, as there is ongoing debate about its effects on the heart. Previous smaller studies suggest it might protect the heart, but large-scale research is needed to confirm these findings and ensure the treatment is safe and beneficial. Participants in this study will be divided into two groups randomly: one group will receive glimepiride, and the other will receive a placebo, which is a harmless pill with no active ingredients. The study will last for 36 months, and participants will visit the clinic at the start and then at regular intervals for follow-ups. Researchers will monitor for serious heart-related events, such as heart-related death, a need for heart transplantation, or worsening heart failure that requires hospitalization or emergency treatment. The study aims to determine if glimepiride can reduce these serious outcomes and improve overall heart health in patients who have both diabetes and heart failure.

Official TitleEfficacy 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.

NCT07288749

Principal SponsorTongji Hospital

Study ContactDao Wen WangMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

1484 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

8 inclusion criteria required to participate

NYHA heart failure classification stage II-IV;

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.

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.

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.

Show More Criteria

15 exclusion criteria prevent from participating

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.

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;

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.

Female patients who are pregnant, planning to become pregnant, or breastfeeding;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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.)

Group II

Placebo

Standardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral placebo (equivalent placebo administered according to the same regimen)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Tongji Hostipal

Wuhan, ChinaOpen Tongji Hostipal in Google Maps

Recruiting soonOne Study Center