A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Envlo Tablet in Patients With Type II Diabetes Mellitus

DWENV_DB_01

This observation study is designed as a prospective, multi-organ observation study to confirm the blood sugar control effect and safety of ENVLO tablet administration for 24 weeks in patients with type 2 diabetes who are scheduled to administer ENVLO tablet in the actual treatment environment.

2023-07-01

2024-12-01

2025-06-01

Not yet recruiting

10000

Inclusion Criteria: 1. an adult male and female over 19 years of age 2. A person who is a type 2 diabetic and is planed to take Envlo Tab. for the first time according to the medical judgment of the Investigator based on the permit 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 Exclusion Criteria: 1. Persons with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.) 2. A person who is prohibited from administering in accordance with the permission of Envlo Tab.'s * Patients who overreact to Envlo Tab. or Envlo Tab. components and have a history of it * eGFR (estimated global filtration rate) patients below 30 mL/min/1.73 m2, 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) 3. Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment 4. Pregnant women and lactating women 5. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices 6. A person who is deemed inappropriate to participate in this observational study based on the judgment of other investigators

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 10000, 'type': 'ESTIMATED'}}

2023-07-03