Efficacy and Safety of Berberine in the Treatment of Diabetes With Dyslipidemia

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human. These findings have not been tested in a clinical trial. This randomized, double blind, placebo controlled and multi-center study has demonstrated that berberine is effective in lowering plasma glucose concentrations, reducing serum HbA1c and anti-dyslipidemia in type 2 diabetic patients with dyslipidemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Criteria

Inclusion Criteria:

1. Age of 25 -70 years;

2. Newly diagnosed type 2 diabetes according to the 1999 World Health Organization criteria;

3. Dyslipidemia with TG> 150mg/dL (1.70mmol/L), and/or TC>200mg/dL (5.16mmol/L), and/or LDL-C>100mg/dL (2.58mmol/L) according to the National Cholesterol Education Program's Adult Treatment Panel III (NCEP: ATPIII) without previous treatment.

4. BMI:19 - 40 kg/m2.

Exclusion Criteria:

1. Moderate or severe liver or renal dysfunction, psychiatric disease or severe infection;

2. Severe dysfunction of the heart，New York Heart Association class ³ Ⅲ phase;

3. History of acute diabetic complications;

4. Pregnancy or planned pregnancy.

5. Present or previous use of drugs for treatment of diabetes or dyslipidemia;

6. Fasting plasma glucose >8mmol/L and/or post load plasma glucose level >17mmol/L after 2-week run-in.