Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Efficacy and Safety of Dehypotin® in the Patients with Type 2 Diabetes Mellitus or Cardiovascular Disease. Eligible patients will be randomly assigned to 1 of 2 arms, either Dehypotin® or placebo, and will receive the diet advisement throughout the study.

Official Title
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Phase IV Study for Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease

Conditions
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Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypercholesterolemia

Intervention / Treatment
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* Drug: Placebo
* Drug: Dehypotin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age 20-75 years Diagnosis of type II Diabetes Mellitus for at least 3 months and/or clinical evident cardiovascular disease (CVD) A hemoglobin A1c concentration has to be < 8% before screening Exclusion Criteria: Women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives Known hypersensitivity to Pravastatin or any of its components Have a history of homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia Significant medical illness Known serious conditions, e.g. serum creatine kinase(CK)levels 2.5 times upper limit of normal Subjects being treated with drugs influence serum lipid concentrations Subjects who have cancer or been receiving the cancer chemotherapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks<br>|
| Active Comparator: Dehypotin<br> | Drug: Dehypotin<br>* Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination |  | 12-week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination |  | 12-week treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Cardiovascular Disease, hypercholesterolemia