Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00425009
First received: January 18, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: Berberine
Drug: Metformin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c at 13 weeks

Secondary Outcome Measures:
  • Blood glucose at 13 weeks
  • Blood lipids at 13 weeks

Estimated Enrollment: 70
Study Start Date: January 2004
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425009

Locations
China
Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China, 200092
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Jun Yin, MD, PhD Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00425009     History of Changes
Other Study ID Numbers: XH-2002-Clin4
Study First Received: January 18, 2007
Last Updated: January 18, 2007
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014