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

NCT05538819 | Completed DMC FDA Drug

• 1 other identifier: TJ-T2D&CHF-Glimepiride
• Study Type: observational
• Target: 1,018
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Type 2 Diabetes; Cardiovascular Mortality; Cohort Study

Keywords

glimepiride; type 2 diabetes; chronic heart failure; cardiovascular mortality

Outcome Measures

Primary Outcomes (2)

• Cardiovascular mortality

  Numbers and dates of death due to cardiovascular diseases in each group

  5 years

• Hospitalizations and emergency visits for heart failure

  Numbers and dates of hospitalizations and emergency for heart failure

  5 years

Secondary Outcomes (2)

• All-cause mortality

  5 years

• Hospitalizations for acute myocardial infarction or stroke

  5 years

Study Arms (2)

Glimepiride group

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

Drug: Glimepiride

Non-glimepiride group

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

Interventions

Glimepiride DRUG

Glimepiride 1-4 mg/day

Also known as: Amaryl

Glimepiride group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to continuous glimepiride use, the patients were divided into glimepiride and non-glimepiride groups. A 1:1 propensity score matching (PSM) analysis was used to balance the confounding factors between the glimepiride treatment and clinical outcomes. The PSM cohort (509:509) was followed up using a telephone questionnaire directly or at an outpatient clinic at our cardiac center. The follow-up deadline was July 1, 2022. According to the follow-up results, the glimepiride group was subdivided into high-dose (2-4 mg/day) and low-dose (1 mg/day) groups.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Dao Wen Wang: lead
• Shanghai Institute of Materia Medica, Chinese Academy of Sciences: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• 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 DERIVED

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: September 14, 2022
• Study Start: June 1, 2017
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-09

Locations

CN (1)