Evaluating Enavogliflozin for Type 2 Diabetes with Hypertension or Dyslipidemia
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
Daewoong Pharmaceutical Co. LTD. · NCT06647888
This study is testing if Enavogliflozin can help adults with type 2 diabetes who also have high blood pressure or cholesterol feel better and stay healthy over 24 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06647888 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old diagnosed with type 2 diabetes and either hypertension or dyslipidemia who are currently receiving or scheduled to receive Enavogliflozin or Envlomet SR.
Not a fit: Patients with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m² or those with diabetes types other than type 2 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of Enavogliflozin for managing type 2 diabetes in patients with coexisting conditions.
How similar studies have performed: While this study is observational and builds on existing knowledge, similar studies have shown promise in evaluating the efficacy of diabetes medications in real-world settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2