Dyslipidemia, Type II Diabetes
Conditions
Brief summary
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.
Interventions
DRUGMetformin/Atorvastatin 1500mg/40mg, QD
DRUGMetformin 1500mg, QD
DRUGAtorvastatin 40mg, QD
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with Dyslipidemia and Type II Diabetes * 19 years later, men and women under the age of 80
Exclusion criteria
* Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study * Subject with type I Diabetes * Subject with hypertension which does not controlled by treatment(have blood pressure \> 180/110mmHg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Change from baseline at 16 weeks | 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 in LDL Cholesterol | Change from baseline at 16 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 16 weeks | 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 |
| Change in lipid variables and the associated rate of change | Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks | 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 |
| 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 | — |
| Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products | Baseline and 16 weeks | — |
| Change in HbA1c | Baseline and 16 weeks | 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 |
Countries
South Korea
Outcome results
None listed