NCT00425009

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Jan 2004

Typical duration for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
Last Updated

January 22, 2007

Status Verified

January 1, 2007

First QC Date

January 18, 2007

Last Update Submit

January 18, 2007

Conditions

Type 2 Diabetes

Keywords

BerberineType 2 diabetesTreatment

Outcome Measures

Primary Outcomes (1)

  • HbA1c at 13 weeks

Secondary Outcomes (2)

  • Blood glucose at 13 weeks

  • Blood lipids at 13 weeks

Interventions

BerberineDRUG
MetforminDRUG

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Liver damage
  • Kidney damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, 200092, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

BerberineMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jun Yin, MD, PhD

    Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 22, 2007

Study Start

January 1, 2004

Study Completion

December 1, 2004

Last Updated

January 22, 2007

Record last verified: 2007-01

Locations

CN(1)