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Clinical Trial Details

Trial ID: L6946
Source ID: NCT06427083
Associated Drug: Envlo Tablet
Title: Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Envlo Tablet|DRUG: Envolomet SR Tablet
Outcome Measures: Primary: change in BMI, change in BMI at 24 weeks from baseline, 24 weeks|change in body weight, change in body weight at 24 weeks from baseline, 24 weeks | Secondary: change in BMI, change in BMI at 12 weeks from baseline, 12 weeks|change in body weight, change in body weight at 12 weeks from baseline, 12 weeks|Proportion of subjects achieving ≥ 5% reduction in BMI, Proportion of subjects achieving ≥ 5% reduction in BMI at 12 weeks compared to baseline, 12 weeks|Proportion of subjects achieving ≥ 5% reduction in BMI, Proportion of subjects achieving ≥ 5% reduction in BMI at 24 weeks compared to baseline, 24 weeks|Proportion of subjects achieving ≥ 5% reduction in weight, Proportion of subjects achieving ≥ 5% reduction in weight at 12 weeks compared to baseline, 12 weeks|Proportion of subjects achieving ≥ 5% reduction in weight, Proportion of subjects achieving ≥ 5% reduction in weight at 24 weeks compared to baseline, 24 weeks|Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.), Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.) at 12 weeks compared to baseline, 12 weeks|Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.), Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.) at 24 weeks compared to baseline, 24 weeks|Change in HbA1c, Change in HbA1c at 12 weeks compared to baseline, 12 weeks|Change in HbA1c, Change in HbA1c at 24 weeks compared to baseline, 24 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|Proportion of subjects achieving HbA1c < 7%, Proportion of subjects achieving HbA1c \< 7% at 12 weeks compared to baseline, 12 weeks|Proportion of subjects achieving HbA1c < 7%, Proportion of subjects achieving HbA1c \< 7% at 24 weeks compared to baseline, 24 weeks|Proportion of subjects achieving HbA1c < 6.5%, Proportion of subjects achieving HbA1c \< 6.5% at 12 weeks compared to baseline, 12 weeks|Proportion of subjects achieving HbA1c < 6.5%, Proportion of subjects achieving HbA1c \< 6.5% at 24 weeks compared to baseline, 24 week|Proportion of subjects achieving therapeutic response [change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) > 0.5% or HbA1c < 7%], Proportion of subjects achieving therapeutic response \[change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) \> 0.5% or HbA1c \< 7%\] at 12 weeks compared to baseline, 12 weeks|Proportion of subjects achieving therapeutic response [change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) > 0.5% or HbA1c < 7%], Proportion of subjects achieving therapeutic response \[change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) \> 0.5% or HbA1c \< 7%\] at 24 weeks compared to baseline, 24 weeks
Sponsor/Collaborators: Sponsor: Daewoong Pharmaceutical Co. LTD.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 240
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-06-11
Completion Date: 2026-06-30
Results First Posted:
Last Update Posted: 2024-07-03
Locations: Kyung Hee University Medical Center, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06427083