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

Nang Kuang Pharmaceutical

Status and phase: Terminated; Phase 4

Conditions: Hypercholesterolemia; Type 2 Diabetes Mellitus; Cardiovascular Disease

Treatments: Drug: Placebo; Drug: Dehypotin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01108978

200911064M

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Dehypotin

Active Comparator group

Treatment:

Drug: Dehypotin