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This observational study is a non-interventional, multi-center, prospective observational study aimed at tracking the efficacy and safety of Envlo or Envlomet SR tablets for 24 weeks in patients with type 2 diabetes and hypertension or dyslipidemia who are currently taking or are scheduled to take Envlo or Envlomet SR tablets in an actual clinical setting.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envlo Tablet | Drug | Envlo Tab. 0.3mg |
| |
| Envlomet SR Tablet | Drug | Envlomet SR Tablet 0.3/ Metformin1,000mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target achievement rates for blood glucose | Target achievement rates for blood glucose at 24 weeks | at 24 weeks |
| Target achievement rates for LDL-C treatment goals | Target achievement rates for LDL-C treatment goals at 24 weeks | at 24 weeks |
| Target control rates for blood pressure | Target control rates for blood pressure at 24 weeks | at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in HbA1c | change in HbA1c at 12 week compared to baseline | 12 week |
| change in HbA1c | change in HbA1c at 24 week compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
Among patients who begin treatment with Envlo Tab/ Envlomet Tab at the time of registration, those with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m²
A patient 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 considered inappropriate to participate in this observational study based on the judgment of investigators
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The proportion of study participants reaching the target blood glucose levels of HbA1c < 7.0% or FPG < 126 mg/dL at the 24-week mark compared to baseline was estimated using PASS 14. The minimum number of participants required to generate a two-sided 95% confidence interval is calculated to be 9,604. Considering an approximate dropout rate of 25%, we plan to recruit a total of 12,000 study participants.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Yeon Baeg | Contact | 82-02-550-8419 | bjy469@daewoong.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sang Hoon Moon | Happy Yonsei Family Medicine Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Happy Yonsei Family Medicine Clinic | Recruiting | Seoul | 12254 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
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| 24 week |
| change in FPG | change in FPG at 12 week compared to baseline | 12 week |
| change in FPG | change in FPG at 24 week compared to baseline | 24 week |
| percentage of subjects achieved HbA1c < 7 % | percentage of subjects achieved HbA1c < 7 % at 12 week compared to baseline | 12 week |
| percentage of subjects achieved HbA1c < 7 % | percentage of subjects achieved HbA1c < 7 % at 24 week compared to baseline | 24 week |
| percentage of subjects achieved HbA1c < 6.5 % | percentage of subjects achieved HbA1c < 6.5 % at 12 week compared to baseline | 12 week |
| percentage of subjects achieved HbA1c < 6.5 % | percentage of subjects achieved HbA1c < 6.5 % at 24 week compared to baseline | 24 week |
| therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) | therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) at 12 week compared to baseline | 12 week |
| therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) | therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) at 24 week compared to baseline | at 24 week |
| change in blood pressure (systolic blood pressure, diastolic blood pressure) | change in blood pressure (systolic blood pressure, diastolic blood pressure) at 12 week compared to baseline | at 12 week |
| change in blood pressure (systolic blood pressure, diastolic blood pressure) | change in blood pressure (systolic blood pressure, diastolic blood pressure) at 24 week compared to baseline | at 24 week |
| change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) | change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 12 week compared to baseline | at 12 week |
| change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) | change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 24 week compared to baseline | at 24 week |
| D004700 | Endocrine System Diseases |