Therapeutic Effects of Berberine in Patients With Type 2 Diabetes | RxWiki

Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.
Condition	Type 2 Diabetes
Intervention	Drug: Berberine Drug: Metformin
Phase	Phase 1/Phase 2
Sponsor	Shanghai Jiao Tong University School of Medicine
Responsible Party	Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier	NCT00425009
First Received	January 18, 2007
Last Updated	January 18, 2007
Last verified	January 2007

Tracking Information[ + expand ][ + ]

First Received Date	January 18, 2007
Last Updated Date	January 18, 2007
Start Date	January 2004
Estimated Primary Completion Date	December 2004
Current Primary Outcome Measures	HbA1c at 13 weeks
Current Secondary Outcome Measures	Blood glucose at 13 weeks Blood lipids at 13 weeks

Descriptive Information[ + expand ][ + ]

Brief Title	Therapeutic Effects of Berberine in Patients With Type 2 Diabetes
Official Title	Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes
Brief Summary	The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.
Detailed 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.
Study Type	Interventional
Study Phase	Phase 1/Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes
Intervention	Drug: Berberine Drug: Metformin
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	70
Estimated Completion Date	December 2004
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	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
Gender	Both
Ages	25 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT00425009
Other Study ID Numbers	XH-2002-Clin4
Has Data Monitoring Committee	Not Provided
Information Provided By	Shanghai Jiao Tong University School of Medicine
Study Sponsor	Shanghai Jiao Tong University School of Medicine
Collaborators	National Institutes of Health (NIH)
Investigators	Principal Investigator: Jun Yin, MD, PhD Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Verification Date	January 2007

Locations[ + expand ][ + ]