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Clinical Trial Details

Trial ID: L6265
Source ID: NCT06647888
Associated Drug: Envlo Tablet
Title: Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Envlo Tablet|DRUG: Envlomet SR Tablet
Outcome Measures: Primary: Target achievement rates for blood glucose, Target achievement rates for blood glucose at 24 weeks, at 24 weeks|Target achievement rates for LDL-C treatment goals, Target achievement rates for LDL-C treatment goals at 24 weeks, at 24 weeks|Target control rates for blood pressure, Target control rates for blood pressure at 24 weeks, at 24 weeks | Secondary: change in HbA1c, change in HbA1c at 12 week compared to baseline, 12 week|change in HbA1c, change in HbA1c at 24 week compared to baseline, 24 week|change in FPG, change in FPG at 12 week compared to baseline, 12 week|change in FPG, change in FPG at 24 week compared to baseline, 24 week|percentage of subjects achieved HbA1c < 7 %, percentage of subjects achieved HbA1c \< 7 % at 12 week compared to baseline, 12 week|percentage of subjects achieved HbA1c < 7 %, percentage of subjects achieved HbA1c \< 7 % at 24 week compared to baseline, 24 week|percentage of subjects achieved HbA1c < 6.5 %, percentage of subjects achieved HbA1c \< 6.5 % at 12 week compared to baseline, 12 week|percentage of subjects achieved HbA1c < 6.5 %, percentage of subjects achieved HbA1c \< 6.5 % at 24 week compared to baseline, 24 week|therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %), therapeutic response(change in HbA1c \> 0.5 % OR HbA1c \< 7 %) at 12 week compared to baseline, 12 week|therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %), therapeutic response(change in HbA1c \> 0.5 % OR HbA1c \< 7 %) at 24 week compared to baseline, at 24 week|change in blood pressure (systolic blood pressure, diastolic blood pressure), change in blood pressure (systolic blood pressure, diastolic blood pressure) at 12 week compared to baseline, at 12 week|change in blood pressure (systolic blood pressure, diastolic blood pressure), change in blood pressure (systolic blood pressure, diastolic blood pressure) at 24 week compared to baseline, at 24 week|change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride), change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 12 week compared to baseline, at 12 week|change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride), change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 24 week compared to baseline, at 24 week
Sponsor/Collaborators: Sponsor: Daewoong Pharmaceutical Co. LTD.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 12000
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-12-03
Completion Date: 2026-06-30
Results First Posted:
Last Update Posted: 2025-01-23
Locations: Happy Yonsei Family Medicine Clinic, Seoul, 12254, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06647888