Diabetes Mellitus, Type 2Phase 3NCT00462046
Efficacy and Safety of Berberine in the Treatment of Diabetes With Dyslipidemia
A Phase 3 study testing Berberine in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human. These findings have not been tested in a clinical trial. This randomized, double blind, placebo controlled and multi-center study has demonstrated that berberine is effective in lowering plasma glucose… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metabolic Syndrome
- What is being tested?
- Berberine
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Sep 2006
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 25 -70 years;
- Newly diagnosed type 2 diabetes according to the 1999 World Health Organization criteria;
- Dyslipidemia with TG> 150mg/dL (1.70mmol/L), and/or TC>200mg/dL (5.16mmol/L), and/or LDL-C>100mg/dL (2.58mmol/L) according to the National Cholesterol Education Program's Adult Treatment Panel III (NCEP: ATPIII) without previous treatment.
- BMI:19 - 40 kg/m2.
Who cannot join
- Moderate or severe liver or renal dysfunction, psychiatric disease or severe infection;
- Severe dysfunction of the heart，New York Heart Association class ³ Ⅲ phase;
- History of acute diabetic complications;
- Pregnancy or planned pregnancy.
- Present or previous use of drugs for treatment of diabetes or dyslipidemia;
- Fasting plasma glucose >8mmol/L and/or post load plasma glucose level >17mmol/L after 2-week run-in.
About this study
Official title: The Efficacy and Safety of Berberine in the Treatment of Type 2 Diabetes With Dyslipidemia
Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human. These findings have not been tested in a clinical trial. This randomized, double blind, placebo controlled and multi-center study has demonstrated that berberine is effective in lowering plasma glucose concentrations, reducing serum HbA1c and anti-dyslipidemia in type 2 diabetic patients with dyslipidemia.
Read the detailed description
Berberine, a natural plant alkaloid, has not been well investigated for clinical application in the treatment of diabetes. The present study evaluated the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia. 116 patients with type 2 diabetes and dyslipidemia were assigned in a randomized, double-blind, and placebo-controlled 4-clinical center study to receive berberine (1.0g daily) or placebo for 3 months. The primary efficacy outcomes were changes in plasma glucose and serum lipid levels. The glucose disposal rate (GDR) was measured using a hyperinsulinemic euglycemic clamp to assess insulin resistance in a randomly selected subjects of 54 patients. The baseline characteristics were similar in berberine and placebo groups. After 3 months, fasting and post load plasma glucose levels, HbA1C, triglyceride, total cholesterol and LDL-C levels were all significantly reduced in the berberine group compared with the placebo group (p<0.0001, p<0.0001, p<0.0001, p=0.002, p<0.0001 and p<0.0001 respectively). The GDR was significantly increased after 3 months of berberine (p=0.037), while no change was found in the placebo group (p=0.86). BMI, systolic blood pressure and serum IL-6 levels were all significantly reduced after treatment in berberine group as compared with the placebo group (p=0.016, p=0.041 and p=0.014, respectively). Our results show berberine to be effective and safe in the treatment of persons with diabetes and dislipidemia. This agent may be useful in the treatment of patients with type 2 diabetes, and could play a role in treatment of metabolic syndrome.
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Syndrome
- Being tested
- Berberine
- Keywords
- Berberine, Type 2 diabetes, Dyslipidemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose levels
OGTT 2h glucose levels
HbA1c
Serum Triglycerides
Serum Total Cholesterol
HDL-c
LDL-c
Secondary outcomes (3)
Glucose Disposal Rate
BMI
Blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startApr 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Xiao-Ying Li, MD,PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462046
- Sponsor's protocol ID
- CCEMD001
- Status last verified
- Apr 2007
- First submitted
- 16 Apr 2007
- Last updated
- 18 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Berberine in the Treatment of Type 2 Diabetes With Dyslipidemia
- ClinicalTrials.gov ID
- NCT00462046
- Acronym / sponsor ID
- CCEMD001
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Syndrome
- Keywords
- Berberine, Type 2 diabetes, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 18 Apr 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.
Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human. These findings have not been tested in a clinical trial. This randomized, double blind, placebo controlled and multi-center study has demonstrated that berberine is effective in lowering plasma glucose concentrations, reducing serum HbA1c and anti-dyslipidemia in type 2 diabetic patients with dyslipidemia.
Detailed description
Berberine, a natural plant alkaloid, has not been well investigated for clinical application in the treatment of diabetes. The present study evaluated the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia. 116 patients with type 2 diabetes and dyslipidemia were assigned in a randomized, double-blind, and placebo-controlled 4-clinical center study to receive berberine (1.0g daily) or placebo for 3 months. The primary efficacy outcomes were changes in plasma glucose and serum lipid levels. The glucose disposal rate (GDR) was measured using a hyperinsulinemic euglycemic clamp to assess insulin resistance in a randomly selected subjects of 54 patients. The baseline characteristics were similar in berberine and placebo groups. After 3 months, fasting and post load plasma glucose levels, HbA1C, triglyceride, total cholesterol and LDL-C levels were all significantly reduced in the berberine group compared with the placebo group (p<0.0001, p<0.0001, p<0.0001, p=0.002, p<0.0001 and p<0.0001 respectively). The GDR was significantly increased after 3 months of berberine (p=0.037), while no change was found in the placebo group (p=0.86). BMI, systolic blood pressure and serum IL-6 levels were all significantly reduced after treatment in berberine group as compared with the placebo group (p=0.016, p=0.041 and p=0.014, respectively). Our results show berberine to be effective and safe in the treatment of persons with diabetes and dislipidemia. This agent may be useful in the treatment of patients with type 2 diabetes, and could play a role in treatment of metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 25 -70 years;
- Newly diagnosed type 2 diabetes according to the 1999 World Health Organization criteria;
- Dyslipidemia with TG> 150mg/dL (1.70mmol/L), and/or TC>200mg/dL (5.16mmol/L), and/or LDL-C>100mg/dL (2.58mmol/L) according to the National Cholesterol Education Program's Adult Treatment Panel III (NCEP: ATPIII) without previous treatment.
- BMI:19 - 40 kg/m2.
Key exclusion criteria (6 listed)
- Moderate or severe liver or renal dysfunction, psychiatric disease or severe infection;
- Severe dysfunction of the heart，New York Heart Association class ³ Ⅲ phase;
- History of acute diabetic complications;
- Pregnancy or planned pregnancy.
- Present or previous use of drugs for treatment of diabetes or dyslipidemia;
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 | – |
Primary outcome
Fasting glucose levels
OGTT 2h glucose levels
HbA1c
Serum Triglycerides
Serum Total Cholesterol
HDL-c
LDL-c
3 secondary outcomes
Glucose Disposal Rate
BMI
Blood pressure
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 18 Apr 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.
Xiao-Ying Li, MD,PhD principal investigator
Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Berberine in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by Shanghai Jiao Tong University School of Medicine.
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 4 inclusion and 6 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 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Fasting glucose levels. The study lists 7 primary outcomes in all. 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 18 Apr 2007.