Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Randomized, Double-blind, Active-controlled, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia

Conditions
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Type II Diabetes, Dyslipidemia

Intervention / Treatment
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* Drug: Metformin/Atorvastatin 1500mg/40mg, QD
* Drug: Metformin 1500mg, QD
* Drug: Atorvastatin 40mg, QD


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin/Atorvastatin<br>Metformin/Atorvastatin, QD | Drug: Metformin/Atorvastatin 1500mg/40mg, QD<br> <br> |
| Placebo Comparator: Metformin<br>Metformin, QD | Drug: Atorvastatin 40mg, QD<br> <br> |
| Placebo Comparator: Atorvastatin<br>Atorvastatin, QD | Drug: Metformin 1500mg, QD<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |