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.
An adult male and female over 19 years of age
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
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
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 who overreact to Envlo Tab or Envlomet Tab components and have a history of it
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.
Case-only
Prospective
Envlo Tablet
DrugEnvlo Tab. 0.3mg
Envlomet SR Tablet
DrugEnvlomet SR Tablet 0.3/ Metformin1,000mg
Target achievement rates for blood glucose
Target achievement rates for blood glucose at 24 weeks
Target achievement rates for LDL-C treatment goals
Target achievement rates for LDL-C treatment goals at 24 weeks
Target control rates for blood pressure
Target control rates for blood pressure at 24 weeks
change in HbA1c
change in HbA1c at 12 week compared to baseline
change in HbA1c
change in HbA1c at 24 week compared to baseline
change in FPG
change in FPG at 12 week compared to baseline
change in FPG
change in FPG at 24 week compared to baseline
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