NCT05926414Active, not recruiting
To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus
A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 2 Sept 2025
Brief summary (registry, in English)
This observation study is designed as a prospective, multi-organ observation study to confirm the blood sugar control effect and safety of ENVLO tablet or Envlomet SR Tablet administration for 24 weeks in patients with type 2 diabetes who are scheduled to administer ENVLO tablet in the actual treatment environment.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 15000 (estimated)
- First submitted
- 22 Jun 2023
- Start date
- 21 Sept 2023
- Primary completion date
- 17 Jan 2025
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05926414
What you commit to
- Study type: Observational
- Planned participants: 15000
- From 21 Sept 2023 to the primary completion date, 17 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Persons with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.)
Lab values
- 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)
Other
- Pregnant women and lactating women
- A person who is deemed inappropriate to participate in this observational study based on the judgment of other investigators
Who the study is looking for
- an adult male and female over 19 years of age
- A person who is a type 2 diabetic and is planed to take Envlo Tab or Envloment SR Tab for the first time according to the medical judgment of the Investigator based on the permit
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NaRi Kim Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.