NaRi Kim
Seoul, South Korea
NCT Number: NCT05926414
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 study is active but is not currently recruiting participants.
Notify Me19 year and older
All sexes
Observational
Seoul, South Korea
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
treated with Envlo tab. 0.3mg
Other names: Envlo Tablet
Time frame: at 24 weeks
change in HbA1c at 24 weeks compared to baseline
Time frame: 12 weeks
change in HbA1c at 12 weeks compared to baseline
Time frame: 12 weeks
change in FPG at 12 weeks compared to baseline
Time frame: 24 weeks
change in FPG at 24 weeks compared to baseline
Time frame: 12 weeks
percentage of subjects achieved HbA1c < 7 % at 12 weeks compared to baseline
Time frame: 24 weeks
percentage of subjects achieved HbA1c < 7 % at 24 weeks compared to baseline
Time frame: 12 weeks
percentage of subjects achieved HbA1c < 6.5 % at 12 weeks compared to baseline
Time frame: 24 weeks
percentage of subjects achieved HbA1c < 6.5 % at 24 weeks compared to baseline
Time frame: 12 weeks
therapeutic response at 12 weeks compared to baseline
Time frame: 24 weeks
therapeutic response at 24 weeks compared to baseline
Daewoong Pharmaceutical Co. LTD.
Industry
A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus
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.
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