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

NCT07288749 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: TJ-GLID-HF
• Study Type: interventional
• Target: 1,484
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Type 2 Diabetes Mellitus (T2DM); Chronic heart failure (CHF); Glimepiride; Randomized clinical trial

Outcome Measures

Primary Outcomes (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.

  3 years

Secondary Outcomes (11)

• All-cause mortality rate

  3 years

• Cardiovascular death, heart transplantation, or readmission due to heart failure

  3 years

• Cardiovascular death, heart transplantation

  3 years

• Rehospitalization due to heart failure

  3 years

• Incidence of discontinuing treatment due to worsening heart failure

  3 years

Study Arms (2)

Glimepiride group

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.)

Drug: Glimepiride (oral)

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.)

Glimepiride group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Huaxi Hospital: collaborator
• Zhongnan Hospital: collaborator
• Xiangya Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• The First Affiliated Hospital of Air Force Medicial University: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Anhui Provincial Hospital: collaborator
• Southwest Medical University: collaborator
• First Hospital of China Medical University: collaborator
• Wuhan Central Hospital: collaborator
• Tianjin Medical University: collaborator
• Tongji Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Nanjing Medical University: collaborator
• Second Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Tongji Hostipal

Wuhan, Hubei, 430030, China

Location

Related Publications (3)

• 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.

  PMID: 34897419 RESULT

• 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.

  PMID: 27653447 RESULT

• 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.

  PMID: 36573717 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employed a double-blind design, meaning that neither the patients, investigators, study coordinators, members of the endpoint adjudication committee, nor the data analysts were aware of the specific group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CN (1)