Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Envlo Tablet, Envlomet SR Tablet.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- Drug Envlo Tablet
Envlo Tab. 0.3mg - Drug Envlomet SR Tablet
Envlomet SR Tablet 0.3/ Metformin1,000mg
Primary outcome measures
- Target achievement rates for blood glucose [Time frame: at 24 weeks]
- Target achievement rates for LDL-C treatment goals [Time frame: at 24 weeks]
- Target control rates for blood pressure [Time frame: at 24 weeks]
Secondary outcome measures (12)
- change in HbA1c [Time frame: 12 week]
- change in HbA1c [Time frame: 24 week]
- change in FPG [Time frame: 12 week]
- change in FPG [Time frame: 24 week]
- percentage of subjects achieved HbA1c < 7 % [Time frame: 12 week]
- percentage of subjects achieved HbA1c < 7 % [Time frame: 24 week]
- percentage of subjects achieved HbA1c < 6.5 % [Time frame: 12 week]
- percentage of subjects achieved HbA1c < 6.5 % [Time frame: 24 week]
- therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) [Time frame: 12 week]
- therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) [Time frame: at 24 week]
- 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) [Time frame: at 24 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Happy Yonsei Family Medicine Clinic — Seoul
Identifiers
NCT: NCT06647888 · DWENV_DB_02