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Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Completed
Phase 2
Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: Berberine
Drug: Metformin

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00425009
XH-2002-Clin4

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

25 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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