Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient diagnosed with type2 diabetes mellitus | patient diagnosed with type2 diabetes mellitus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enavogliflozin | Drug | treated with Envlo tab. 0.3mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in HbA1c | change in HbA1c at 24 weeks compared to baseline | at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in HbA1c | change in HbA1c at 12 weeks compared to baseline | 12 weeks |
| change in FPG | change in FPG at 12 weeks compared to baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
A person who is deemed inappropriate to participate in this observational study based on the judgment of other investigators
Not provided
Not provided
Not provided
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
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NaRi Kim | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Enavogliflozin | Drug | Envlomet SR Tablet 0.3/1,000mg |
|
|
| 12 weeks |
| change in FPG | change in FPG at 24 weeks compared to baseline | 24 weeks |
| percentage of subjects achieved HbA1c < 7 % | percentage of subjects achieved HbA1c < 7 % at 12 weeks compared to baseline | 12 weeks |
| percentage of subjects achieved HbA1c < 7 % | percentage of subjects achieved HbA1c < 7 % at 24 weeks compared to baseline | 24 weeks |
| percentage of subjects achieved HbA1c < 6.5 % | percentage of subjects achieved HbA1c < 6.5 % at 12 weeks compared to baseline | 12 weeks |
| percentage of subjects achieved HbA1c < 6.5 % | percentage of subjects achieved HbA1c < 6.5 % at 24 weeks compared to baseline | 24 weeks |
| therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) | therapeutic response at 12 weeks compared to baseline | 12 weeks |
| therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) | therapeutic response at 24 weeks compared to baseline | 24 weeks |
| D004700 | Endocrine System Diseases |