A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients

NCT06642623 | Recruiting Phase 4 DMC

• 1 other identifier: 4-2023-1334
• Study Type: interventional
• Target: 2,862
• Locations: 1 country
• Sites: 1

Brief Summary

The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor, enavogliflozin, effectively reduces glycated hemoglobin (HbA1c) levels and body weight without increasing the risk of serious adverse events. However, its long-term clinical benefits concerning cardiovascular and renal outcomes have yet to be thoroughly studied. This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults aged 19 or older with type 2 diabetes who have a history of, or are at risk for, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular and renal events. This trial aims to determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with type 2 diabetes and cardiovascular risk factors. It will also clarify role of enavogliflozin in preventing vascular complications in this patient population.

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Time from randomization to first onset of cardiorenal composite outcome event

  Major adverse cardiovascular events include nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina, hospitalization for heart failure, coronary or peripheral revascularization, and death from any cause. Renal events include a sustained decline in estimated glomerular filtration rate (GFR) calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation of ≥40% from baseline to \<60 mL/min/1.73m2, onset of end-stage kidney disease (dialysis for ≥28 days, kidney transplantation, or an estimated GFR of \<15 mL/min/1.73m2), development of macroalbuminuria, and death from renal causes.

  6 months, 12 months, 24 months, 36 months and 48 month

Secondary Outcomes (8)

• Time from randomization to the first onset of 3-point MACE and proportion of the patients

  6 months, 12 months, 24 months, 36 months and 48 months

• death from any cause

  6 months, 12 months, 24 months, 36 months and 48 months

• death from cardiovascular causes

  6 months, 12 months, 24 months, 36 months and 48 months

• hospitalization due to unstable angina

  6 months, 12 months, 24 months, 36 months and 48 months

• hospitalization due to heart failure

  6 months, 12 months, 24 months, 36 months and 48 months

Study Arms (2)

Enavogliflozin Group

EXPERIMENTAL

Subjects will take Enavogliflozin according to the investigator's judgment.

Drug: Enavogliflozin

Dapagliflozin, Empagliflozin Group

ACTIVE COMPARATOR

Subjects will take Dapagliflozin or Empagliflozin according to the investigator's judgment.

Drug: Dapagliflozin or Empagliflozin

Interventions

Enavogliflozin DRUG

The dosage and administration method are determined according to the investigator's judgment, considering the drug's approval requirements and the medical condition of the study participants.

Enavogliflozin Group

Dapagliflozin or Empagliflozin DRUG

The dosage and administration method are determined according to the investigator's judgment, considering the drug's approval requirements and the medical condition of the study participants.

Dapagliflozin, Empagliflozin Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults aged 19 years and older at screening
• Subjects diagnosed with T2D at screening
• Subjects on treatment with or requiring treatment with enavogliflozin, dapagliflozin, or empagliflozin within the scope of label and reimbursement criteria

You may not qualify if:

• Subjects with different types of diabetes mellitus other than T2D
• Subjects with moderate to severe hepatic impairment
• Subjects with contraindications to SGLT-2 inhibitors, i.e., kidney function disorders with estimated glomerular filtration (eGFR) \<60 mL/min/1.73 m2, end stage renal disease (ESRD), or on dialysis
• Subjects with major comorbidities
• Subjects with a history of hypersensitivity to enavogliflozin, dapagliflozin, or empagliflozin and any of its components
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Kidney Diseases

Interventions

Enavogliflozin; dapagliflozin; empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: his study was designed as a pragmatic clinical trial(pracmatic RCT), which demonstrates the real-world effectiveness of the intervention in broad patient groups.

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: January 22, 2024
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)