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

This study has been completed.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00462046
First received: April 16, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Metabolic Syndrome
 Drug: Berberine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Berberine in the Treatment of Type 2 Diabetes With Dyslipidemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Fasting glucose levels
  • OGTT 2h glucose levels
  • HbA1c
  • Serum Triglycerides
  • Serum Total Cholesterol
  • HDL-c
  • LDL-c

Secondary Outcome Measures:
  • Glucose Disposal Rate
  • BMI
  • Blood pressure

Estimated Enrollment: 120
Study Start Date: April 2005
Study Completion Date: September 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462046

Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Xiao-Ying Li, MD,PhD Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00462046     History of Changes
Other Study ID Numbers: CCEMD001
Study First Received: April 16, 2007
Last Updated: April 16, 2007
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Berberine
Type 2 diabetes
Dyslipidemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Metabolic Syndrome X
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on May 21, 2013