Happy Yonsei Family Medicine Clinic
Seoul, 12254, South Korea
Location status: Recruiting
NCT Number: NCT06647888
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.
Interested in participating?
Request Info19 year and older
All sexes
Observational
Seoul, 12254, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Envlo Tab. 0.3mg
Other names: Enavogliflozin 0.3mg
Envlomet SR Tablet 0.3/ Metformin1,000mg
Other names: Enavogliflozin 0.3mg/ Metformin1,000mg
Time frame: at 24 weeks
Target achievement rates for blood glucose at 24 weeks
Time frame: at 24 weeks
Target achievement rates for LDL-C treatment goals at 24 weeks
Time frame: at 24 weeks
Target control rates for blood pressure at 24 weeks
Time frame: 12 week
change in HbA1c at 12 week compared to baseline
Time frame: 24 week
change in HbA1c at 24 week compared to baseline
Time frame: 12 week
change in FPG at 12 week compared to baseline
Time frame: 24 week
change in FPG at 24 week compared to baseline
Time frame: 12 week
percentage of subjects achieved HbA1c < 7 % at 12 week compared to baseline
Time frame: 24 week
percentage of subjects achieved HbA1c < 7 % at 24 week compared to baseline
Time frame: 12 week
percentage of subjects achieved HbA1c < 6.5 % at 12 week compared to baseline
Time frame: 24 week
percentage of subjects achieved HbA1c < 6.5 % at 24 week compared to baseline
Time frame: 12 week
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) at 12 week compared to baseline
Time frame: at 24 week
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) at 24 week compared to baseline
Time frame: at 12 week
change in blood pressure (systolic blood pressure, diastolic blood pressure) at 12 week compared to baseline
Time frame: at 24 week
change in blood pressure (systolic blood pressure, diastolic blood pressure) at 24 week compared to baseline
Time frame: at 12 week
change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 12 week compared to baseline
Time frame: at 24 week
change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 24 week compared to baseline
Contact information is provided by the study sponsor or research team.
Daewoong Pharmaceutical Co. LTD.
Industry
A Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Enavogliflozin in Patients With Type II Diabetes Mellitus Accompanied by Hypertension or Dyslipidemia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07242469
Diabetes Mellitus, Diabetes Mellitus, Type 2
Anaheim, California, United States
View Trial DetailsNCT07532863
Diabetes Mellitus, Diabetes Mellitus, Type 2
Tangerang, Banten, Indonesia
View Trial DetailsNCT05962372
Abdominal Obesity, Body Weight
San Juan, Puerto Rico
View Trial DetailsNCT07215559
Body Weight, Diabetes Mellitus
Gilbert, Arizona, United States
View Trial Details