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Type 2 Diabetes Mellitus (T2DM)Phase 3GLID-HFNCT07288749

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

A Phase 3 study testing Glimepiride (oral) in people with Type 2 Diabetes Mellitus (T2DM) and Chronic Heart Failure (CHF), run by Tongji Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Glimepiride (oral)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,484 participants
Where
1 siteChina
Study dates
1 Jan 2026to 31 Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • 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.
  • NT-proBNP levels ≥ 600 pg/mL in patients with no recent hospitalization for heart failure; NT-proBNP levels ≥ 400 pg/mL within the past 12 months due to heart failure hospitalization; NT-proBNP levels ≥ 900 pg/mL in patients with heart failure complicated by atrial fibrillation/flutter.
  • 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.
  • Participation is voluntary and requires signing an informed consent form; follow-up can extend beyond three years.

Who cannot join

  • 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.
  • Chronic kidney disease stage 3b or more advanced renal impairment (i.e., estimated glomerular filtration rate [eGFR]/creatinine clearance [CrCl] <45 ml/min);
  • Left ventricular outflow tract obstruction, acute or fulminant myocarditis, aortic aneurysm, aortic dissection, or significant hemodynamic changes caused by unrepaired valves;
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  • Cardiac shock, uncontrollable malignant arrhythmias, second-degree or higher sinus or atrioventricular block without pacemaker therapy, progressive unstable angina pectoris, or acute myocardial infarction;
  • 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;
  • Female patients who are pregnant, planning to become pregnant, or breastfeeding;
  • Patients who have participated in any other investigational medicinal product clinical trial within the past 4 weeks;
  • Patients with a history of allergies or hypersensitivity to glimepiride or its derivatives;
  • Received glimepiride treatment within 8 weeks prior to enrollment or previously demonstrated intolerance to glimepiride;
  • Patients refusing to comply with study requirements to complete the research;
  • Conditions where the investigator deems the patient unable to understand and/or comply with study medications, procedures, or any other circumstances that may prevent completion of the study;
  • Any other reason deemed inappropriate for inclusion by the study physician.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dao Wen Wang contact

+86-027-6937-8422

dwwang@tjh.tjmu.edu.cn

Li Ni contact

+86-027-8366-2479

nili@tjh.tjmu.edu.cn

China1 site

  • Tongji Hostipal

    Wuhan, Hubei, 430030

    Dao Wen Wang, +86-027-6937-8422, dwwang@tjh.tjmu.edu.cn

    Li Ni, +8613407192299, nili@tjh.tjmu.edu.cn

Other trials in China

About this study

Official title: 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.

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.

Read the 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.

Being tested
Glimepiride (oral), Placebo
Keywords
Type 2 Diabetes Mellitus (T2DM), Chronic heart failure (CHF), Glimepiride, Randomized clinical trial
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glimepiride (oral)Drug

    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.)

  • PlaceboDrug

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

Study groups in NCT07288749
Study groupRoleWhat they receive
Glimepiride groupExperimentalStandardized 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.)
Receives: Drug: Glimepiride (oral)
Placebo groupPlacebo comparatorStandardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral placebo (equivalent placebo administered according to the same regimen)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

Secondary outcomes (11)

  1. 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.

    Measured: 3 years

  2. 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).

    Measured: 3 years

  3. 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).

    Measured: 3 years

  4. Rehospitalization due to heart failure

    Time to first rehospitalization due to heart failure (defined as the primary endpoint).

    Measured: 3 years

  5. 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.

    Measured: 3 years

  6. 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.).

    Measured: 3 years

  7. 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]).

    Measured: 3 years

  8. 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%.

    Measured: 3 years

  9. 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.

    Measured: 3 years

  10. Changes in 6-Minute Walk Test (6MWT) Results

    Change in 6-minute walk distance (6MWD) from baseline to follow-up (in meters).

    Measured: 3 years

  11. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,484 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07288749
Sponsor's protocol ID
TJ-GLID-HF
Acronym
GLID-HF
Status last verified
Dec 2025
First submitted
5 Dec 2025
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Karwi QG, Ho KL, Pherwani S, Ketema EB, Sun Q, Lopaschuk GD. Corrigendum to: Concurrent diabetes and heart failure: interplay and novel therapeutic approaches. Cardiovasc Res. 2022 Jun 22;118(7):1850. doi: 10.1093/cvr/cvab355. No abstract available.

    PubMed 34897419

  • Fitchett DH, Udell JA, Inzucchi SE. Heart failure outcomes in clinical trials of glucose-lowering agents in patients with diabetes. Eur J Heart Fail. 2017 Jan;19(1):43-53. doi: 10.1002/ejhf.633. Epub 2016 Sep 21.

    PubMed 27653447

  • He W, Yuan G, Han Y, Yan Y, Li G, Zhao C, Shen J, Jiang X, Chen C, Ni L, Wang DW. Glimepiride Use is Associated with Reduced Cardiovascular Mortality in Patients with Type 2 Diabetes and Chronic Heart Failure: A Prospective Cohort Study. Eur J Prev Cardiol. 2022 Dec 27:zwac312. doi: 10.1093/eurjpc/zwac312. Online ahead of print.

    PubMed 36573717

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glimepiride (oral) in people with Type 2 Diabetes Mellitus (T2DM) and Chronic Heart Failure (CHF), run by Tongji Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dao Wen Wang (+86-027-6937-8422, dwwang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07288749, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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