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Clinical Trial Details

Trial ID: L2211
Source ID: NCT03739125
Associated Drug: Ckd-501 0.5mg
Title: Efficacy and Safety of CKD-501 Added to D150 Plus D745 10mg Therapy in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes
Interventions: DRUG: CKD-501 0.5mg|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in Glycosylated Hemoglobin (HbA1c), Baseline, 24 weeks | Secondary: Change from baseline in Glycosylated Hemoglobin (HbA1c), Baseline, 52 weeks|Change from baseline in Fasting plasma glucose, Baseline, 24 weeks, 52weeks|Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance), Baseline, 24 weeks, 52weeks|Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function), Baseline, 24 weeks, 52weeks|Change from baseline in QUICKI(Quantitative Insulin Check Index), Baseline, 24 weeks, 52weeks|HbA1c target achievement rate at 24, 52weeks(HbA1c < 6.5%, 7%), Baseline, 24 weeks, 52weeks|Change from baseline in Total Cholesterol, Baseline, 24 weeks, 52weeks|Change from baseline in Triglycerides, Baseline, 24 weeks, 52weeks|Change from baseline in LDL-Cholesterol, Baseline, 24 weeks, 52weeks|Change from baseline in HDL-Cholesterol, Baseline, 24 weeks, 52weeks|Change from baseline in non-HDL-Cholesterol, Baseline, 24 weeks, 52weeks|Change from baseline in Small Dense LDL-Cholesterol, Baseline, 24 weeks, 52weeks|Change from baseline in FFA(Free Fatty Acid), Baseline, 24 weeks, 52weeks|Change from baseline in Apo-AⅠ, Baseline, 24 weeks, 52weeks|Change from baseline in Apo-B, Baseline, 24 weeks, 52weeks|Change from baseline in Apo-CⅢ, Baseline, 24 weeks, 52weeks|Evaluate safety of CKD-501 from number of participants with adverse events, Baseline, 24 weeks, 52weeks
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 226
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-11-07
Completion Date: 2020-12-02
Results First Posted:
Last Update Posted: 2021-08-25
Locations: Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03739125