Type 2 DiabetesPhase 1/2NCT00425009
Therapeutic Effects of Berberine in Patients With Type 2 Diabetes
A Phase 1/2 study testing Berberine and Metformin in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Berberine and Metformin
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jan 2004to Dec 2004
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Liver damage
- Kidney damage
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200092
About this study
Official title: Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes
The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Berberine, Metformin
- Keywords
- Berberine, Type 2 diabetes, Treatment
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
MetforminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c at 13 weeks
Secondary outcomes (2)
Blood glucose at 13 weeks
Blood lipids at 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startJan 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Jun Yin, MD, PhD, Principal investigator, Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425009
- Sponsor's protocol ID
- XH-2002-Clin4
- Status last verified
- Jan 2007
- First submitted
- 18 Jan 2007
- Last updated
- 22 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00425009
- Acronym / sponsor ID
- XH-2002-Clin4
- Conditions
- Type 2 Diabetes
- Keywords
- Berberine, Type 2 diabetes, Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2004
- Study completion
- Dec 2004
- First posted
- 22 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Liver damage
- Kidney damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berberine | Drug | – |
| Metformin | Drug | – |
Primary outcome
HbA1c at 13 weeks
2 secondary outcomes
Blood glucose at 13 weeks
Blood lipids at 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Yin, MD, PhD principal investigator
Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Berberine and Metformin in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c at 13 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2007.