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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01108978
• Other study ID #: 200911064M
• Status: Terminated
• Phase: Phase 4
• First received: April 21, 2010
• Last updated: June 7, 2011
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Nang Kuang Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypercholesterolemia
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Taiwan	Nang Kuang Pharmaceutical Co., LTD	Tainan	Xinhua Township

Sponsors (2)

Lead Sponsor	Collaborator
Nang Kuang Pharmaceutical Co., Ltd.	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination		12-week treatment	Yes
Secondary	Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination		12-week treatment	Yes