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Clinical Trial Details

Trial ID: L3536
Source ID: NCT05043467
Associated Drug: Duvie(Lobeglitazone) Tab 0.5mg
Title: Retrospective Study to Evaluate the Safety of Duvie in Korean Patients With Type 2 Diabetes Mellitus
Acronym: DISCOVERY
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes
Interventions: DRUG: Duvie(Lobeglitazone) tab 0.5mg
Outcome Measures: Primary: Incidence of major adverse events (AEs) and any AEs that occurred during the administration period of lobeglitazone, Investigators identified the following as major AEs: edema, weight gain(in kilograms), fractures, bladder cancer, anemia, hypoglycemia, macular edema, cardiac death, myocardial Infarction, stroke, transient ischemic attack, coronary arterial occlusion, and CHF. Investigators also identified any AEs including blood pressure(in millimeter of mercury) change, increased liver enzyme (\> 3X), and dizziness., during the administration period of lobeglitazone | Secondary: Changes in glycated hemoglobin (HbA1c) and glucose, lipid parameters, Investigators identified changes in glycated hemoglobin (HbA1c in percentage) and glucose(in milligrams per deciliter), lipid parameters in milligrams per deciliter(total cholesterol, triglyceride, low-density lipoprotein \[LDL\] cholesterol, and high-density lipoprotein \[HDL\] cholesterol) at 3, 6, 12, 18, 24, 36, 42, and 48 months after administration of lobeglitazone., 3, 6, 12, 18, 24, 36, 42, and 48 months after administration of lobeglitazone
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 2228
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2019-01-02
Completion Date: 2020-06-19
Results First Posted:
Last Update Posted: 2021-09-14
Locations: Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05043467