Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
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.
Interventions
DRUGEnvlo Tablet
Envlo Tab. 0.3mg
DRUGEnvlomet SR Tablet
Envlomet SR Tablet 0.3/ Metformin1,000mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. An adult male and female over 19 years of age 2. A patient diagnosed with type 2 diabetes who have hypertension or dyslipidemia and are currently receiving Envlo Tab/ Envlomet SR Tab or are scheduled to receive Envlo Tab/ Envlomet SR Tab 3. 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 4 ) A person who understands the content of this observational study, are cooperative with the research process, and are considered capable of participating until the study's completion
Exclusion criteria
1. 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 2. A patient with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.) 3. A person who is prohibited from administering in accordance with the permission of Envlo Tab's * Patients who overreact to Envlo Tab or Envlomet Tab components and have a history of it * Patients with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m², 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) 4. Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment 5. Pregnant women and lactating women 6. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices 7. A person who is considered inappropriate to participate in this observational study based on the judgment of investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target achievement rates for blood glucose | at 24 weeks | Target achievement rates for blood glucose at 24 weeks |
| Target achievement rates for LDL-C treatment goals | at 24 weeks | Target achievement rates for LDL-C treatment goals at 24 weeks |
| Target control rates for blood pressure | at 24 weeks | Target control rates for blood pressure at 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of subjects achieved HbA1c < 6.5 % | 12 week | percentage of subjects achieved HbA1c \< 6.5 % at 12 week compared to baseline |
| therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) | 12 week | therapeutic response(change in HbA1c \> 0.5 % OR HbA1c \< 7 %) at 12 week compared to baseline |
| change in HbA1c | 12 week | change in HbA1c at 12 week compared to baseline |
| change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) | at 12 week | change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 12 week compared to baseline |
| change in blood pressure (systolic blood pressure, diastolic blood pressure) | at 12 week | change in blood pressure (systolic blood pressure, diastolic blood pressure) at 12 week compared to baseline |
| change in FPG | 12 week | change in FPG at 12 week compared to baseline |
| percentage of subjects achieved HbA1c < 7 % | 12 week | percentage of subjects achieved HbA1c \< 7 % at 12 week compared to baseline |
Countries
South Korea
Contacts
Primary ContactJi Yeon Baeg
Outcome results
None listed