Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425009
• Other study ID #: XH-2002-Clin4
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 18, 2007
• Last updated: January 18, 2007
• Start date: January 2004
• Est. completion date: December 2004

Study information

• Verified date: January 2007
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.

Description:

Type 2 diabetes is health threats worldwide. However, treatment of this disease is limited by availability of effective medicines. All of the existing oral hypoglycemic agents have secondary failure after long term administration. Thus, new oral medicines are needed for long term control of blood glucose in patients with type 2 diabetes. In diabetes care, dietary approaches have drawn more and more attention in the prevention and treatment of hyperglycemia. Generally regarded as safe (GRAS) plants have been widely used for their benefits in antioxidation, anti-inflammation, anticancer, anti-obesity and anti-diabetes. Numerous botanical products such as pigments that include anthocyanins and flavonoids have been consumed or studied for anti-obesity and anti-diabetes. However, most of these botanical products are mixtures of multiple compounds. It is difficult to control their quality in the study or production. Up to now, as a single purified compound, berberine is demonstrated to have hypoglycemic effect in vitro and in vivo. Berberine is the main active component of Coptis chinensis French, which was used for thousands of years in China in the treatment of human diseases including diabetes.

Comparison(s): Effects of berberine compared with metformin in newly diagnosed type 2 diabetic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes

• HbA1c > 7.0% or FBG > 7.0 mmol/L

• Stable or worsening glycemic control for at least 3 months

Exclusion Criteria:

• Liver damage

• Kidney damage

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Berberine

• Metformin

Locations

Country	Name	City	State
China	Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c at 13 weeks
Secondary	Blood glucose at 13 weeks
Secondary	Blood lipids at 13 weeks