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Clinical Trial Details

Trial ID: L3494
Source ID: NCT05926414
Associated Drug: Enavogliflozin
Title: To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Enavogliflozin|DRUG: Enavogliflozin
Outcome Measures: Primary: change in HbA1c, change in HbA1c at 24 weeks compared to baseline, at 24 weeks | Secondary: change in HbA1c, change in HbA1c at 12 weeks compared to baseline, 12 weeks|change in FPG, change in FPG at 12 weeks compared to baseline, 12 weeks|change in FPG, change in FPG at 24 weeks compared to baseline, 24 weeks|percentage of subjects achieved HbA1c < 7 %, percentage of subjects achieved HbA1c \< 7 % at 12 weeks compared to baseline, 12 weeks|percentage of subjects achieved HbA1c < 7 %, percentage of subjects achieved HbA1c \< 7 % at 24 weeks compared to baseline, 24 weeks|percentage of subjects achieved HbA1c < 6.5 %, percentage of subjects achieved HbA1c \< 6.5 % at 12 weeks compared to baseline, 12 weeks|percentage of subjects achieved HbA1c < 6.5 %, percentage of subjects achieved HbA1c \< 6.5 % at 24 weeks compared to baseline, 24 weeks|therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %), therapeutic response at 12 weeks compared to baseline, 12 weeks|therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %), therapeutic response at 24 weeks compared to baseline, 24 weeks
Sponsor/Collaborators: Sponsor: Daewoong Pharmaceutical Co. LTD.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 15000
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2023-09-21
Completion Date: 2025-06-30
Results First Posted:
Last Update Posted: 2025-03-10
Locations: NaRi Kim, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05926414

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress