Efficacy Evaluation of Glimepiride in Patients With Type 2 Diabetes Mellitus and Chronic Heart Failure With Reduced Ejection Fraction.
NCT ID: NCT07288749
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
1484 participants
INTERVENTIONAL
2026-01-01
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Glimepiride group
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 (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.)
Placebo group
Standardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral placebo (equivalent placebo administered according to the same regimen)
Placebo
Standardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral placebo (equivalent placebo administered according to the same regimen)
Interventions
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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.)
Placebo
Standardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral placebo (equivalent placebo administered according to the same regimen)
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. NYHA heart failure classification stage II-IV;
5. 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.
6. 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.
7. 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.
8. Participation is voluntary and requires signing an informed consent form; follow-up can extend beyond three years.
Exclusion Criteria
2. Currently experiencing acute decompensated heart failure (ADHF) or hospitalized for ADHF within the previous four weeks before enrollment.
3. 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.
4. 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.
5. Chronic kidney disease stage 3b or more advanced renal impairment (i.e., estimated glomerular filtration rate \[eGFR\]/creatinine clearance \[CrCl\] \<45 ml/min);
6. Left ventricular outflow tract obstruction, acute or fulminant myocarditis, aortic aneurysm, aortic dissection, or significant hemodynamic changes caused by unrepaired valves;
7. Cardiac shock, uncontrollable malignant arrhythmias, second-degree or higher sinus or atrioventricular block without pacemaker therapy, progressive unstable angina pectoris, or acute myocardial infarction;
8. 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;
9. Female patients who are pregnant, planning to become pregnant, or breastfeeding;
10. Patients who have participated in any other investigational medicinal product clinical trial within the past 4 weeks;
11. Patients with a history of allergies or hypersensitivity to glimepiride or its derivatives;
12. Received glimepiride treatment within 8 weeks prior to enrollment or previously demonstrated intolerance to glimepiride;
13. Patients refusing to comply with study requirements to complete the research;
14. 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;
15. Any other reason deemed inappropriate for inclusion by the study physician.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Nanjing Medical University
OTHER
Second Xiangya Hospital of Central South University
OTHER
Huaxi Hospital
OTHER
Zhongnan Hospital
OTHER
Xiangya Hospital
OTHER
Beijing Anzhen Hospital
OTHER
The First Affiliated Hospital of Air Force Medicial University
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Anhui Provincial Hospital
OTHER_GOV
Southwest Medical University
OTHER
First Hospital of China Medical University
OTHER
Wuhan Central Hospital
OTHER
Tianjin Medical University
OTHER
Tongji Hospital
OTHER
Responsible Party
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Dao Wen Wang
Prof.
Locations
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Tongji Hostipal
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Dao Wen Wang
Role: primary
Li Ni
Role: backup
References
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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.
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.
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.
Other Identifiers
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TJ-GLID-HF
Identifier Type: -
Identifier Source: org_study_id