Tracks enavogliflozin tablets in type 2 diabetes with high blood pressure or cholesterol
Follows adults with type 2 diabetes and high blood pressure or cholesterol taking enavogliflozin tablets.
Plain-language title generated from the registry record
Registry title: Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Happy Yonsei Family Medicine ClinicSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Daewoong Pharmaceutical Co. LTD.
- Trial code
- NCT06647888
- Record updated
- 23 January 2025
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment; A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices; A patient with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.); 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 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); Pregnant women and lactating women; A person who is considered inappropriate to participate in this observational study based on the judgment of investigators.