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Diabetes Mellitus, Type 2Phase 4ENVELOPNCT06642623

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

A Phase 4 study testing Enavogliflozin and Dapagliflozin or Empagliflozin in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Yonsei University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Enavogliflozin and Dapagliflozin or Empagliflozin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,862 participants
Where
1 siteSouth Korea
Study dates
22 Jan 2024to 31 Dec 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

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

    Seoul, 03722

    Bong Soo Cha, MD, PhD, +82-2-2228-1962, bscha@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: A Prospective, Open, Registry-based Randomized, Controlled, Investigator Initiated Trial of Enavogliflozin(ENVlo) to EvaLuate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients (ENVELOP Study)

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.

Read the detailed description

The ENVELOP study aims to assess cardiorenal outcomes following enavogliflozin administration compared with dapagliflozin or empagliflozin in Korean patients with type 2 diabetes, representing the first large-scale SGLT2 inhibitor outcome study targeting this population.

Being tested
Enavogliflozin, Dapagliflozin or Empagliflozin
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnavogliflozinDrug

    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 or EmpagliflozinDrug

    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.

Study groups in NCT06642623
Study groupRoleWhat they receive
Enavogliflozin GroupExperimentalSubjects will take Enavogliflozin according to the investigator's judgment.
Receives: Drug: Enavogliflozin
Dapagliflozin, Empagliflozin GroupActive comparatorSubjects will take Dapagliflozin or Empagliflozin according to the investigator's judgment.
Receives: Drug: Dapagliflozin or Empagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)

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

    Time to first event of a composite of key major adverse cardiovascular events (non-fatal MI, non-fatal stroke, and death from cardiovascular causes)

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

  2. death from any cause

    Time to death from any cause

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

  3. death from cardiovascular causes

    Time to death from cardiovascular cause

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

  4. hospitalization due to unstable angina

    Time to first event of hospitalization due to unstable angina

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

  5. hospitalization due to heart failure

    Time to first event of hospitalization due to heart failure

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

  6. coronary or peripheral revascularization

    Time to first event of coronary or peripheral revascularization

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

  7. major renal events

    Time to first event of a composite of major kidney events

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

  8. progression of macroalbuminuria

    Time to development of macroalbuminuria

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start22 Jan 2024
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
his study was designed as a pragmatic clinical trial(pracmatic RCT), which demonstrates the real-world effectiveness of the intervention in broad patient groups.
Masking
None (open label)
Enrolment
2,862 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06642623
Sponsor's protocol ID
4-2023-1334
Acronym
ENVELOP
Status last verified
Oct 2024
First submitted
13 Oct 2024
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enavogliflozin and Dapagliflozin or Empagliflozin in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from randomization to first onset of cardiorenal composite outcome event (time frame: 6 months, 12 months, 24 months, 36 months and 48 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06642623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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