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Clinical Trial Details

Trial ID: L2080
Source ID: NCT02947620
Associated Drug: Metformin/Atorvastatin 1500mg/40mg, Qd
Title: Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type II Diabetes|Dyslipidemia
Interventions: DRUG: Metformin/Atorvastatin 1500mg/40mg, QD|DRUG: Metformin 1500mg, QD|DRUG: Atorvastatin 40mg, QD
Outcome Measures: Primary: Change in HbA1c, Change in HbA1c after 16 weeks, relative to baseline, between the combination of Metformin 1500 mg and Atorvastatin 40 mg compared to Atorvastatin 40 mg alone, Change from baseline at 16 weeks|Change in LDL Cholesterol, Change in low-density lipoprotein cholesterol (LDL-C) after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg, Change from baseline at 16 weeks | Secondary: Change in LDL-C, Change in LDL-C after 16 weeks, relative to baseline, between Atorvastatin 40 mg and the combination of Metformin 1500 mg and Atorvastatin 40 mg, Baseline and 16 weeks|Change in HbA1c, Change in HbA1c after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg, Baseline and 16 weeks|Percentage of subjects reaching the LDL-C treatment goal defined by the NCEP ATP III guideline (<100mg/dL) after 16 weeks of treatment with investigational products, 16 weeks|Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products, 16 weeks|Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline, Baseline, 4 weeks, 8 weeks and 12 weeks|Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products, Baseline and 16 weeks|Change in lipid variables and the associated rate of change, Change in lipid variables (HDL-C, TG, TC, non-HDL cholesterol, Apolipoprotein A1, Apolipoprotein B) and the associated rate of change after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline, Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks|Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline, Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks|Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline., Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Sponsor/Collaborators: Sponsor: Daewoong Pharmaceutical Co. LTD.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 185
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-08
Completion Date: 2017-02-27
Results First Posted:
Last Update Posted: 2023-06-18
Locations: Samsung Medical Center, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02947620