Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin/Atorvastatin | Active Comparator | Metformin/Atorvastatin, QD |
|
| Metformin | Placebo Comparator | Metformin, QD |
|
| Atorvastatin | Placebo Comparator | Atorvastatin, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin/Atorvastatin 1500mg/40mg, QD | Drug |
| ||
| Metformin 1500mg, QD |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Atorvastatin 40mg, QD | Drug |
|
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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided