A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
185
Samsung Medical Center
Seoul, South Korea
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
Time frame: 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
Time frame: Change from baseline at 16 weeks
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
Time frame: 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
Time frame: 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
Time frame: 16 weeks
Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products
Time frame: 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
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks