Trials / Active Not Recruiting
Active Not RecruitingNCT05926414
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 15,000 (estimated)
- Sponsor
- Daewoong Pharmaceutical Co. LTD. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enavogliflozin | treated with Envlo tab. 0.3mg |
| DRUG | Enavogliflozin | Envlomet SR Tablet 0.3/1,000mg |
Timeline
- Start date
- 2023-09-21
- Primary completion
- 2025-01-17
- Completion
- 2025-12-31
- First posted
- 2023-07-03
- Last updated
- 2025-09-02
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05926414. Inclusion in this directory is not an endorsement.