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.
Study Type
OBSERVATIONAL
Enrollment
12,000
Envlo Tab. 0.3mg
Envlomet SR Tablet 0.3/ Metformin1,000mg
Happy Yonsei Family Medicine Clinic
Seoul, South Korea
RECRUITINGTarget achievement rates for blood glucose
Target achievement rates for blood glucose at 24 weeks
Time frame: at 24 weeks
Target achievement rates for LDL-C treatment goals
Target achievement rates for LDL-C treatment goals at 24 weeks
Time frame: at 24 weeks
Target control rates for blood pressure
Target control rates for blood pressure at 24 weeks
Time frame: at 24 weeks
change in HbA1c
change in HbA1c at 12 week compared to baseline
Time frame: 12 week
change in HbA1c
change in HbA1c at 24 week compared to baseline
Time frame: 24 week
change in FPG
change in FPG at 12 week compared to baseline
Time frame: 12 week
change in FPG
change in FPG at 24 week compared to baseline
Time frame: 24 week
percentage of subjects achieved HbA1c < 7 %
percentage of subjects achieved HbA1c \< 7 % at 12 week compared to baseline
Time frame: 12 week
percentage of subjects achieved HbA1c < 7 %
percentage of subjects achieved HbA1c \< 7 % at 24 week compared to baseline
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Time frame: 24 week
percentage of subjects achieved HbA1c < 6.5 %
percentage of subjects achieved HbA1c \< 6.5 % at 12 week compared to baseline
Time frame: 12 week
percentage of subjects achieved HbA1c < 6.5 %
percentage of subjects achieved HbA1c \< 6.5 % at 24 week compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 24 week