Evaluating Enavogliflozin for Type 2 Diabetes with Hypertension or Dyslipidemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to track the efficacy and safety of Enavogliflozin (Envlo) and Envlomet SR tablets in patients with type 2 diabetes who also have hypertension or dyslipidemia. It will recruit adult participants who are currently taking or are scheduled to take these medications, collecting data on their health outcomes over a 24-week period. The study will gather information from medical records in a real-world clinical setting without requiring mandatory visits or examinations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. An adult male and female over 19 years of age
2. 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
3. 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:

1. 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
2. A patient with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.)
3. 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)
4. Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment
5. Pregnant women and lactating women
6. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices
7. A person who is considered inappropriate to participate in this observational study based on the judgment of investigators

Where it's running

• Happy Yonsei Family Medicine Clinic
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Sang Hoon Moon — Happy Yonsei Family Medicine Clinic
• Study coordinator: Ji Yeon Baeg
• Email: bjy469@daewoong.co.kr
• Phone: 82-02-550-8419

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.