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.
Study Type
OBSERVATIONAL
Enrollment
15,000
treated with Envlo tab. 0.3mg
Envlomet SR Tablet 0.3/1,000mg
NaRi Kim
Seoul, South Korea
change in HbA1c
change in HbA1c at 24 weeks compared to baseline
Time frame: at 24 weeks
change in HbA1c
change in HbA1c at 12 weeks compared to baseline
Time frame: 12 weeks
change in FPG
change in FPG at 12 weeks compared to baseline
Time frame: 12 weeks
change in FPG
change in FPG at 24 weeks compared to baseline
Time frame: 24 weeks
percentage of subjects achieved HbA1c < 7 %
percentage of subjects achieved HbA1c \< 7 % at 12 weeks compared to baseline
Time frame: 12 weeks
percentage of subjects achieved HbA1c < 7 %
percentage of subjects achieved HbA1c \< 7 % at 24 weeks compared to baseline
Time frame: 24 weeks
percentage of subjects achieved HbA1c < 6.5 %
percentage of subjects achieved HbA1c \< 6.5 % at 12 weeks compared to baseline
Time frame: 12 weeks
percentage of subjects achieved HbA1c < 6.5 %
percentage of subjects achieved HbA1c \< 6.5 % at 24 weeks compared to baseline
Time frame: 24 weeks
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
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therapeutic response at 12 weeks compared to baseline
Time frame: 12 weeks
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
therapeutic response at 24 weeks compared to baseline
Time frame: 24 weeks