Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00425009

Enrollment

Registered

2007-01-22

Start date

2004-01-31

Completion date

2004-12-31

Last updated

2007-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Berberine, Type 2 diabetes, Treatment

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.

Interventions

DRUGBerberine

DRUGMetformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HbA1c at 13 weeks	—

Secondary

Measure	Time frame
Blood glucose at 13 weeks	—
Blood lipids at 13 weeks	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026