Diabetes Mellitus, Type 2NCT05926414
To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 2, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Enavogliflozin
- Type of treatment
- Pill or oral medicine
- How many people
- 15,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is an observational study conducted in a single group, and was calculated using the Confidence Intervals for One Mean method for the mean by referring to the average and standard deviation of changes at 12 or 24 weeks compared to the baseline of HbA1c levels in previous phase 2 and 3 clinical trials
Who may be able to join
- 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
Who cannot join
- Persons 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 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)
Show all 10Show fewer
- 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 deemed inappropriate to participate in this observational study based on the judgment of other investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Diabetes Mellitus, Type 2
- Being tested
- Enavogliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnavogliflozinDrug
Also called Envlo Tablet
treated with Envlo tab. 0.3mg
EnavogliflozinDrug
Also called Envlomet SR Tablet
Envlomet SR Tablet 0.3/1,000mg
| Study group | Role | What they receive |
|---|---|---|
| patient diagnosed with type2 diabetes mellitus | patient diagnosed with type2 diabetes mellitus Receives: Drug: Enavogliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1c
change in HbA1c at 24 weeks compared to baseline
Measured: at 24 weeks
Secondary outcomes (9)
change in HbA1c
change in HbA1c at 12 weeks compared to baseline
Measured: 12 weeks
change in FPG
change in FPG at 12 weeks compared to baseline
Measured: 12 weeks
change in FPG
change in FPG at 24 weeks compared to baseline
Measured: 24 weeks
percentage of subjects achieved HbA1c < 7 %
percentage of subjects achieved HbA1c < 7 % at 12 weeks compared to baseline
Measured: 12 weeks
percentage of subjects achieved HbA1c < 7 %
percentage of subjects achieved HbA1c < 7 % at 24 weeks compared to baseline
Measured: 24 weeks
percentage of subjects achieved HbA1c < 6.5 %
percentage of subjects achieved HbA1c < 6.5 % at 12 weeks compared to baseline
Measured: 12 weeks
percentage of subjects achieved HbA1c < 6.5 %
percentage of subjects achieved HbA1c < 6.5 % at 24 weeks compared to baseline
Measured: 24 weeks
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
therapeutic response at 12 weeks compared to baseline
Measured: 12 weeks
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
therapeutic response at 24 weeks compared to baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start21 Sep 2023
- Primary completion17 Jan 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926414
- Sponsor's protocol ID
- DWENV_DB_01
- Status last verified
- Aug 2025
- First submitted
- 22 Jun 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05926414
- Acronym / sponsor ID
- DWENV_DB_01
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient diagnosed with type2 diabetes mellitus | – | Drug: Enavogliflozinpatient diagnosed with type2 diabetes mellitus |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is an observational study conducted in a single group, and was calculated using the Confidence Intervals for One Mean method for the mean by referring to the average and standard deviation of changes at 12 or 24 weeks compared to the baseline of HbA1c levels in previous phase 2 and 3 clinical trials
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Persons 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnavogliflozinAlso: Envlo Tablettreated with Envlo tab. 0.3mg | Drug | patient diagnosed with type2 diabetes mellitus |
| EnavogliflozinAlso: Envlomet SR TabletEnvlomet SR Tablet 0.3/1,000mg | Drug | patient diagnosed with type2 diabetes mellitus |
Primary outcome
change in HbA1c
Time frame: at 24 weeks
change in HbA1c at 24 weeks compared to baseline
9 secondary outcomes
change in HbA1c
Time frame: 12 weeks
change in FPG
Time frame: 12 weeks
change in FPG
Time frame: 24 weeks
percentage of subjects achieved HbA1c < 7 %
Time frame: 12 weeks
percentage of subjects achieved HbA1c < 7 %
Time frame: 24 weeks
percentage of subjects achieved HbA1c < 6.5 %
Time frame: 12 weeks
percentage of subjects achieved HbA1c < 6.5 %
Time frame: 24 weeks
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
Time frame: 12 weeks
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in HbA1c (time frame: at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.