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Clinical Trial Details

Trial ID: L2862
Source ID: NCT06772168
Associated Drug: Cmg190303(Dapagliflozin/Rosuvastatin)
Title: Evaluate the Efficacy and Safety of CMG190303 in Patients with Type 2 Diabetes and Dyslipidemia
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Dyslipidemia|Type 2 Diabetes
Interventions: DRUG: CMG190303(Dapagliflozin/Rosuvastatin)|DRUG: Comparator 1: Dapagliflozin/Rosuvastatin placebo|DRUG: Rosuvastatin/Dapagliflozin placebo
Outcome Measures: Primary: To compare the change in HbA1c (%) from baseline to 24 weeks between the dapagliflozin and rosuvastatin combination group and the rosuvastatin monotherapy group, From enrollment to the end of treatment at 24 weeks|To compare the percentage change in LDL-C from baseline to 24 weeks between the dapagliflozin and rosuvastatin combination group and the dapagliflozin monotherapy group, From enrollment to the end of treatment at 24 weeks | Secondary: To compare the change in HbA1c (%) from baseline to 24 weeks between the dapagliflozin and rosuvastatin combination group and the dapagliflozin monotherapy group, From enrollment to the end of treatment at 24 weeks|The percentage change in LDL-C from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product, From enrollment to the end of treatment at 24 weeks|The proportion of subjects achieving LDL-C target levels by cardiovascular risk category from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product, From enrollment to 8, 16, and 24 weeks|The change in fasting plasma glucose (FPG) (mg/dL) from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product, From enrollment to 8, 16, and 24 weeks|The percentage change in the following lipid parameters from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product:, Total cholesterol (TC) (mg/dL) Triglyceride (TG) (mg/dL) HDL-C (mg/dL) Non-HDL-C (mg/dL) ApoB (mg/dL), ApoAI (mg/dL), ApoB/ApoAI Ratio, From enrollment to 8, 16, and 24 weeks|The change in HbA1c (%) from baseline to 24 weeks in the rosuvastatin monotherapy group, From enrollment to the end of treatment at 24 weeks | Other: The proportion of subjects with HbA1c < 6.5% at 8, 16, and 24 weeks from baseline after administration of the investigational medicinal product, From enrollment to 8, 16, and 24 weeks|The change in blood pressure (SBP/DBP) (mmHg) from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product, From enrollment to 8, 16, and 24 weeks|The change in body weight (kg) from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product, From enrollment to 8, 16, and 24 weeks|The proportion of subjects who used rescue medication and the associated change in HbA1c (%) from baseline to 24 weeks, From enrollment to 8, 16, and 24 weeks
Sponsor/Collaborators: Sponsor: CMG Pharmaceutical Co. Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 240
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-19
Completion Date: 2026-08-01
Results First Posted:
Last Update Posted: 2025-01-15
Locations: Hallym university sungsim medical center, Anyang, 14068, Korea, Republic of|Buchon sejong hospital, Buchon, 14754, Korea, Republic of|Inje university heaundea paik hospital, Busan, 48108, Korea, Republic of|Soonchunhyang cheonan university hospital, Cheonan, 31151, Korea, Republic of|Daejeon eulji medical center, eulji university, Daejeon, 35233, Korea, Republic of|Hanyang University Medical Center, Guri, 11923, Korea, Republic of|Chosun University Hospital, Gwangju, 61453, Korea, Republic of|Wonkwang university hospital, Iksan, 54538, Korea, Republic of|Inha university hospital, Inchon, 22332, Korea, Republic of|Chonbuk National University Hospital, Jeonju, 54907, Korea, Republic of|Bundang CHA medical center, Seongnam, 13496, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam, 13620, Korea, Republic of|Nowon eulji medical center, eulji university, Seoul, 01830, Korea, Republic of|Korea University ANAM Hospital, Seoul, 02841, Korea, Republic of|Severance hospital, Seoul, 03722, Korea, Republic of|Kyung hee university hospital at gangdong, Seoul, 05278, Korea, Republic of|The Catholic University of Korea, Seoul ST. Mary's Hospital, Seoul, 06591, Korea, Republic of|Hallym university gangnam medical center, Seoul, 07441, Korea, Republic of|Korea University Guro Hospital, Seoul, 08308, Korea, Republic of|Wonju serverance christian hospital, Wonju, 26426, Korea, Republic of|Yongin Severance Hospital, Yongin-si, 16995, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06772168