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

Last updated: April 16, 2007
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

High Cholesterol (Hyperlipidemia)

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT00462046
CCEMD001
  • Ages 25-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age of 25 -70 years;

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

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

  4. BMI:19 – 40 kg/m2.

Exclusion

Exclusion Criteria:

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

  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.

Study Design

Total Participants: 120
Study Start date:
April 01, 2005
Estimated Completion Date:
September 30, 2006

Study Description

Berberine, a natural plant alkaloid, has not been well investigated for clinical application in the treatment of diabetes. The present study evaluated the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia. 116 patients with type 2 diabetes and dyslipidemia were assigned in a randomized, double-blind, and placebo-controlled 4-clinical center study to receive berberine (1.0g daily) or placebo for 3 months. The primary efficacy outcomes were changes in plasma glucose and serum lipid levels. The glucose disposal rate (GDR) was measured using a hyperinsulinemic euglycemic clamp to assess insulin resistance in a randomly selected subjects of 54 patients. The baseline characteristics were similar in berberine and placebo groups. After 3 months, fasting and post load plasma glucose levels, HbA1C, triglyceride, total cholesterol and LDL-C levels were all significantly reduced in the berberine group compared with the placebo group (p<0.0001, p<0.0001, p<0.0001, p=0.002, p<0.0001 and p<0.0001 respectively). The GDR was significantly increased after 3 months of berberine (p=0.037), while no change was found in the placebo group (p=0.86). BMI, systolic blood pressure and serum IL-6 levels were all significantly reduced after treatment in berberine group as compared with the placebo group (p=0.016, p=0.041 and p=0.014, respectively). Our results show berberine to be effective and safe in the treatment of persons with diabetes and dislipidemia. This agent may be useful in the treatment of patients with type 2 diabetes, and could play a role in treatment of metabolic syndrome.