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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01108978

Enrollment

Registered

2010-04-22

Start date

2010-05-31

Completion date

2011-05-31

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Hypercholesterolemia, Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Cardiovascular Disease, hypercholesterolemia

Brief summary

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.

Interventions

DRUGPlacebo

Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks

DRUGDehypotin

Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026