EGPT2D&CHF: The Effects of Glimepiride in Patients With Type 2 Diabetes and Chronic Heart Failure

Sponsor

Tongji Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05538819

Collaborator

Shanghai Institute of Materia Medica, Chinese Academy of Sciences (Other)

1,018

Enrollment

Location

Actual Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure Type 2 Diabetes Cardiovascular Mortality Cohort Study	Drug: Glimepiride

Detailed 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.11 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%.16 Although some studies have shown that SUs are neutral in terms of hospitalization rates and adverse cardiovascular events in patients with CHF,17 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1018 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2017

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Glimepiride group 509 patients aged >18 years with T2D and CHF had continuous glimepiride use (1-4 mg/day).	Drug: Glimepiride Glimepiride 1-4 mg/day Other Names: Amaryl
Non-glimepiride group 509 patients aged >18 years with T2D and CHF had no glimepiride use.

Arm

Intervention/Treatment

Glimepiride group

509 patients aged >18 years with T2D and CHF had continuous glimepiride use (1-4 mg/day).

Drug: Glimepiride

Glimepiride 1-4 mg/day

Other Names:

Amaryl

Non-glimepiride group

509 patients aged >18 years with T2D and CHF had no glimepiride use.

Outcome Measures

Primary Outcome Measures

Cardiovascular mortality [5 years]
Numbers and dates of death due to cardiovascular diseases in each group
Hospitalizations and emergency visits for heart failure [5 years]
Numbers and dates of hospitalizations and emergency for heart failure

Secondary Outcome Measures

All-cause mortality [5 years]
Numbers and dates of death in each group
Hospitalizations for acute myocardial infarction or stroke [5 years]
Numbers and dates of hospitalizations for acute myocardial infarction or stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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)