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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Efficacy and Safety of Berberine in the Treatment of Type 2 Diabetes With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462046
• Other study ID #: CCEMD001
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2007
• Last updated: April 16, 2007
• Start date: April 2005
• Est. completion date: September 2006

Study information

• Verified date: April 2007
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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 ? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemias
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Berberine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose levels
Primary	OGTT 2h glucose levels
Primary	HbA1c
Primary	Serum Triglycerides
Primary	Serum Total Cholesterol
Primary	HDL-c
Primary	LDL-c
Secondary	Glucose Disposal Rate
Secondary	BMI
Secondary	Blood pressure