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NCT Number: NCT06647888

Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Happy Yonsei Family Medicine Clinic

Seoul, 12254, South Korea

Location status: Recruiting

Location contact

Sang Hoon Moon

CONTACT

031-554-6060

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Envlo Tablet

Drug

Envlo Tab. 0.3mg

Other names: Enavogliflozin 0.3mg

Envlomet SR Tablet

Drug

Envlomet SR Tablet 0.3/ Metformin1,000mg

Other names: Enavogliflozin 0.3mg/ Metformin1,000mg

Primary outcomes

  1. Target achievement rates for blood glucose

    Time frame: at 24 weeks

    Target achievement rates for blood glucose at 24 weeks

  2. Target achievement rates for LDL-C treatment goals

    Time frame: at 24 weeks

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

  3. Target control rates for blood pressure

    Time frame: at 24 weeks

    Target control rates for blood pressure at 24 weeks

Secondary outcomes

  1. change in HbA1c

    Time frame: 12 week

    change in HbA1c at 12 week compared to baseline

  2. change in HbA1c

    Time frame: 24 week

    change in HbA1c at 24 week compared to baseline

  3. change in FPG

    Time frame: 12 week

    change in FPG at 12 week compared to baseline

  4. change in FPG

    Time frame: 24 week

    change in FPG at 24 week compared to baseline

  5. percentage of subjects achieved HbA1c < 7 %

    Time frame: 12 week

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

  6. percentage of subjects achieved HbA1c < 7 %

    Time frame: 24 week

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

  7. percentage of subjects achieved HbA1c < 6.5 %

    Time frame: 12 week

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

  8. percentage of subjects achieved HbA1c < 6.5 %

    Time frame: 24 week

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

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

    Time frame: 12 week

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

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

    Time frame: at 24 week

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

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

    Time frame: at 12 week

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

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

    Time frame: at 24 week

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

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

    Time frame: at 12 week

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

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

    Time frame: at 24 week

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ji Yeon Baeg

CONTACT

[email protected]

82-02-550-8419

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 18, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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