The Effects of Glimepiride in Patients With Type 2 Diabetes and Chronic Heart Failure

Type 2 Diabetes Clinical Trial

— EGPT2D&CHF  

Official title:

The Effects of Glimepiride in Patients With Type 2 Diabetes and Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538819
• Other study ID #: TJ-T2D&CHF-Glimepiride
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Thirty years ago, Dzau and Braunwald introduced the concept of a continuum of cardiovascular diseases and defined them as a series of events caused by numerous related and unrelated risk factors, thus developing to end-stage heart disease through many pathophysiological pathways and processes. Owing to treatment concept changes and the urgency of investigating T2D combined with CHF, SUs are being re-evaluated, of which glimepiride is undoubtedly the most promising.

Description:

Since the first sulfonylurea (SU; tolbutamide) was commercially launched in Germany in 1956, SUs, as the oldest oral hypoglycemic drugs, have been developed for three generations and are commonly used for patients with T2D. In 2008, the US Food and Drug Administration and European Drug Administration required cardiovascular safety certification for all hypoglycemic drugs, resulting in increased related clinical trials. Currently, data on the relationship between SUs and cardiovascular outcomes are limited, and the cardiovascular effects remain controversial in observational studies. Third-generation SUs, such as glimepiride, are widely used for treating T2D because of their definite hypoglycemic efficacy, relatively low risk of hypoglycemia, convenient daily use, and low price. Glimepiride has good cardiovascular safety according to randomized controlled trials (RCTs). The proportion of SUs used in patients with heart failure is as high as 60.4%. Although some studies have shown that SUs are neutral in terms of hospitalization rates and adverse cardiovascular events in patients with CHF, no standard RCT of glimepiride has been conducted to study its effect on the prognosis of patients with T2D and confirmed CHF. Glimepiride inhibits soluble epoxide hydrolase (sEH), thus reducing epoxyeicosatrienoic acid (EET) degradation . Increased EET production exerts protective effects on the heart, indicating the potential cardiovascular effect of glimepiride. This retrospective cohort study aimed to evaluate the effects of glimepiride on the clinical outcomes of patients with T2D and CHF and provide theoretical evidence for the clinical application of glimepiride in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1018
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic heart failure (>6 months duration, according to 2021 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure)
• Reduced ejection fraction defined as LVEF < 50%
• N-terminal pro-brain natriuretic peptide (NT-proBNP) level: >125 pg/mL
• NYHA-class II/III/IV with stable symptoms for at least the past 3 months
• Type 2 diabetes (according to the Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022)

Exclusion Criteria:

• Those who did not meet the diagnostic criteria
• Lacked echocardiographic and NT-proBNP data
• Used sulfonylureas other than glimepiride were excluded

Related Conditions & MeSH terms

• Cardiovascular Mortality
• Chronic Heart Failure
• Cohort Study
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Type 2 Diabetes

Intervention

Drug:
• Glimepiride
Glimepiride 1-4 mg/day

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Dao Wen Wang	Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality	Numbers and dates of death due to cardiovascular diseases in each group	5 years
Primary	Hospitalizations and emergency visits for heart failure	Numbers and dates of hospitalizations and emergency for heart failure	5 years
Secondary	All-cause mortality	Numbers and dates of death in each group	5 years
Secondary	Hospitalizations for acute myocardial infarction or stroke	Numbers and dates of hospitalizations for acute myocardial infarction or stroke	5 years