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Diabetes Mellitus, Type 2NCT06647888

Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia

An observational study of Diabetes Mellitus, Type 2, run by Daewoong Pharmaceutical Co. LTD. 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

This observational study is a non-interventional, multi-center, prospective observational study aimed at tracking the efficacy and safety of Envlo or Envlomet SR tablets for 24 weeks in patients with type 2 diabetes and hypertension or dyslipidemia who are currently taking or are scheduled to take Envlo or Envlomet SR… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Envlo Tablet and Envlomet SR Tablet
Type of treatment
Pill or oral medicine
How many people
12,000 participants
Where
1 siteSouth Korea
Study dates
3 Dec 2024to 30 Jun 2026
Phase
Observational
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

Study population: The proportion of study participants reaching the target blood glucose levels of HbA1c < 7.0% or FPG < 126 mg/dL at the 24-week mark compared to baseline was estimated using PASS 14. The minimum number of participants required to generate a two-sided 95% confidence interval is calculated to be 9,604. Considering an approximate dropout rate of 25%, we plan to recruit a total of 12,000 study participants.

Who may be able to join

  • An adult male and female over 19 years of age
  • A patient diagnosed with type 2 diabetes who have hypertension or dyslipidemia and are currently receiving Envlo Tab/ Envlomet SR Tab or are scheduled to receive Envlo Tab/ Envlomet SR Tab
  • A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied 4 ) A person who understands the content of this observational study, are cooperative with the research process, and are considered capable of participating until the study's completion

Who cannot join

  • Among patients who begin treatment with Envlo Tab/ Envlomet Tab at the time of registration, those with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m²
  • A patient with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.)
  • A person who is prohibited from administering in accordance with the permission of Envlo Tab's
  • Patients who overreact to Envlo Tab or Envlomet Tab components and have a history of it
  • Patients with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m², end-stage renal disease, or on dialysis
  • Patients with moderate and severe liver failure (AST or ALT > 3x normal upper limit, Total Bilirubin > 2x normal upper limit, hepatitis or liver failure)
Show all 11Show fewer
  • Class III or IV by classification of the New York Heart Association (NYHA)
  • Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment
  • Pregnant women and lactating women
  • A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices
  • A person who is considered inappropriate to participate in this observational study based on the judgment of investigators

Trial locations and contacts

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

Ji Yeon Baeg contact

82-02-550-8419

bjy469@daewoong.co.kr

South Korea1 site, 1 recruiting

  • Happy Yonsei Family Medicine Clinic

    Seoul, 12254

    Sang Hoon Moon, 031-554-6060

    Recruiting

Other trials in South Korea

About this study

Official title: A Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Enavogliflozin in Patients With Type II Diabetes Mellitus Accompanied by Hypertension or Dyslipidemia

This observational study is a non-interventional, multi-center, prospective observational study aimed at tracking the efficacy and safety of Envlo or Envlomet SR tablets for 24 weeks in patients with type 2 diabetes and hypertension or dyslipidemia who are currently taking or are scheduled to take Envlo or Envlomet SR tablets in an actual clinical setting.

Read the detailed description

This observational study planned recruit population of type 2 diabetes patients who are scheduled to administer Envlo tablet or Envlomet SR Tablet according to the medical judgment of the researcher (doctor in charge) based on permission (efficacy \& effect, usage \& dose, usage precautions, etc.) in the actual treatment environment.

This observational study will be conducted in an actual treatment environment regardless of whether Envlo tablet or Envlomet SR Tablet was administered or not.

Information such as demographic information, body measurement, and vital signs performed will be collected up to 24 weeks after Envlo tablet or Envlomet SR Tablet administration.

Data will be collected based on medical records recorded in the actual treatment environment, and there is no mandatory visit, examination, or treatment in this observation study.

Being tested
Envlo Tablet, Envlomet SR Tablet
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Envlo TabletDrug

    Also called Enavogliflozin 0.3mg

    Envlo Tab. 0.3mg

  • Envlomet SR TabletDrug

    Also called Enavogliflozin 0.3mg/ Metformin1,000mg

    Envlomet SR Tablet 0.3/ Metformin1,000mg

What is being measured

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

  1. Target achievement rates for blood glucose

    Target achievement rates for blood glucose at 24 weeks

    Measured: at 24 weeks

  2. Target achievement rates for LDL-C treatment goals

    Target achievement rates for LDL-C treatment goals at 24 weeks

    Measured: at 24 weeks

  3. Target control rates for blood pressure

    Target control rates for blood pressure at 24 weeks

    Measured: at 24 weeks

Secondary outcomes (14)

  1. change in HbA1c

    change in HbA1c at 12 week compared to baseline

    Measured: 12 week

  2. change in HbA1c

    change in HbA1c at 24 week compared to baseline

    Measured: 24 week

  3. change in FPG

    change in FPG at 12 week compared to baseline

    Measured: 12 week

  4. change in FPG

    change in FPG at 24 week compared to baseline

    Measured: 24 week

  5. percentage of subjects achieved HbA1c < 7 %

    percentage of subjects achieved HbA1c < 7 % at 12 week compared to baseline

    Measured: 12 week

  6. percentage of subjects achieved HbA1c < 7 %

    percentage of subjects achieved HbA1c < 7 % at 24 week compared to baseline

    Measured: 24 week

  7. percentage of subjects achieved HbA1c < 6.5 %

    percentage of subjects achieved HbA1c < 6.5 % at 12 week compared to baseline

    Measured: 12 week

  8. percentage of subjects achieved HbA1c < 6.5 %

    percentage of subjects achieved HbA1c < 6.5 % at 24 week compared to baseline

    Measured: 24 week

  9. therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)

    therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) at 12 week compared to baseline

    Measured: 12 week

  10. therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)

    therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) at 24 week compared to baseline

    Measured: at 24 week

  11. change in blood pressure (systolic blood pressure, diastolic blood pressure)

    change in blood pressure (systolic blood pressure, diastolic blood pressure) at 12 week compared to baseline

    Measured: at 12 week

  12. change in blood pressure (systolic blood pressure, diastolic blood pressure)

    change in blood pressure (systolic blood pressure, diastolic blood pressure) at 24 week compared to baseline

    Measured: at 24 week

  13. change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride)

    change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 12 week compared to baseline

    Measured: at 12 week

  14. change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride)

    change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 24 week compared to baseline

    Measured: at 24 week

Timeline

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

  1. First posted18 Oct 2024
  2. Study start3 Dec 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
12,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06647888
Sponsor's protocol ID
DWENV_DB_02
Status last verified
Jan 2025
First submitted
16 Oct 2024
Last updated
23 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Daewoong Pharmaceutical Co. LTD. 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 11 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 23 Jan 2025. 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.

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?

Contact Ji Yeon Baeg (82-02-550-8419, bjy469@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target achievement rates for blood glucose (time frame: at 24 weeks). The study lists 3 primary outcomes in all. 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 NCT06647888.

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 23 Jan 2025.

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