Type 2 Diabetes MellitusPhase 2/3NCT02084004
Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment
A Phase 2/3 study testing Bifidobacterium viable pharmaceutics and Berberine Hydrochloride in people with Type 2 Diabetes Mellitus, run by Xijing Hospital at 4 sites in China.
Trial summary
The aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride and Berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect the potential mechanism. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Bifidobacterium viable pharmaceutics and Berberine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesChina
- Study dates
- Nov 2015to Apr 2018
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities；
- Male or female between 18 and 70 years of age
- 19≤Body mass index(BMI)≤30kg/m2
- No participate in any clinical trial at least 3 months
- Newly diagnosed T2DM (OGTT) or not received previous pharmacological treatment
- 7%≤HbA1c≤9%
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- Females in child-bearing period should be given birth control
- No severe disease about heart, lung and kidney
- Ability and willingness to adhere to the protocol including performance of self-monitored blood glucose (SMBG) profiles according to the protocol
- Subject is likely to comply with the Investigators instruction
Who cannot join
- Type 2 or 1 diabetes mellitus received previous pharmacological treatment
- Females of childbearing potential who are pregnant，breastfeeding or intend to become pregnant or are not using adequate contraceptive methods
- Impaired liver function, defined as Aspartate aminotransferase（AST） or Alanine transaminase (ALT)> 2 times upper limit of normal (central laboratory)
- Impaired renal function, defined as serum-creatinine≥133μmol/L
- Uncontrolled treated/untreated severe hypertension (systolic blood pressure≥160mmHg and /or diastolic blood pressure≥95mmHg)
- Chronic gastrointestinal diseases
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- Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
- Any clinically significant disease or disorder, which in the Investigator's opinion could interfere with the results of the trial
- Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read and write
- Previous participation in this trial. Participation is defined as randomized. Re-screening of screening failures is allowed only once within the limits of the recruitment period
- Known or suspected hypersensitivity to trial products or related products
- Known or suspected abuse of alcohol, narcotics or illicit drugs
Trial locations and contacts
4 sites in 1 country.
China4 sites
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
The 323rd Hospital of People's Liberation Army
Xi'an, Shaanxi, 710054
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
About this study
Official title: Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment：an Open-label, Multicenter，Randomized, Prospective，Controlled Study
The aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride and Berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect the potential mechanism.
Read the detailed description
Gut microbiota maybe play an important role in patients with type 2 diabetes mellitus (T2DM). Berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, the aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride and Berberine on lowering glucose in patients with T2DM and to detect the potential mechanism.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Bifidobacterium viable pharmaceutics, Berberine Hydrochloride
- Keywords
- Type 2 diabetes mellitus, Berberine Hydrochloride, Bifidobacterium
- 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.
Bifidobacterium viable pharmaceuticsDrug
Berberine HydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium viable pharmaceutics | Experimental | Bifidobacterium viable pharmaceutics, 2 Capsules, 2/day, 12 weeks Receives: Drug: Bifidobacterium viable pharmaceutics |
| Berberine Hydrochloride | Experimental | Berberine Hydrochloride, 0.5g, 2/day, 12 weeks Receives: Drug: Berberine Hydrochloride |
| lifestyle counseling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to week 12
Change was measured at baseline and week 12 after randomization. Change was reported as the absolute difference in % HbA1c.
Measured: Baseline and week 12
Secondary outcomes (4)
Percentage of subjects achieving HbA1c < 7% at week 12
Measured: Week 12
Gut microbiome composition
Faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in feces.
Measured: Baseline and week 12
Changes in postprandial glucagon-like peptide-1 (GLP-1) secretion between baseline and week 12
Plasma level of GLP-1 at baseline and week 12 during a 2 hour-meal test.
Measured: Baseline and week 12
Adverse effects
Standardized questionaries regarding gastrointestinal function are filled out at each study visit (0, 4, 8 and 12 weeks after randomization) to detect possible adverse effects of antibiotics. In addition, subjects are given a calendar and informed to write down any symptom or illness during the study period.
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startNov 2015 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: The sponsor have not enough money to support this trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiuhe Ji, Ph.D.,M.D., Principal investigator, Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084004
- Sponsor's protocol ID
- 2013KTZB03-02-01A
- Status last verified
- Nov 2018
- First submitted
- 27 Feb 2014
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment：an Open-label, Multicenter，Randomized, Prospective，Controlled Study
- ClinicalTrials.gov ID
- NCT02084004
- Acronym / sponsor ID
- 2013KTZB03-02-01A
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Berberine Hydrochloride, Bifidobacterium
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor have not enough money to support this trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Nov 2015 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 11 Mar 2014 (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 aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride and Berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect the potential mechanism.
Detailed description
Gut microbiota maybe play an important role in patients with type 2 diabetes mellitus (T2DM). Berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, the aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride and Berberine on lowering glucose in patients with T2DM and to detect the potential mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium viable pharmaceutics | Experimental | Drug: Bifidobacterium viable pharmaceuticsBifidobacterium viable pharmaceutics, 2 Capsules, 2/day, 12 weeks |
| Berberine Hydrochloride | Experimental | Drug: Berberine HydrochlorideBerberine Hydrochloride, 0.5g, 2/day, 12 weeks |
| lifestyle counseling | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed consent obtained before any trial-related activities；
- Male or female between 18 and 70 years of age
- 19≤Body mass index(BMI)≤30kg/m2
- No participate in any clinical trial at least 3 months
- Newly diagnosed T2DM (OGTT) or not received previous pharmacological treatment
Key exclusion criteria (12 listed)
- Type 2 or 1 diabetes mellitus received previous pharmacological treatment
- Females of childbearing potential who are pregnant，breastfeeding or intend to become pregnant or are not using adequate contraceptive methods
- Impaired liver function, defined as Aspartate aminotransferase（AST） or Alanine transaminase (ALT)> 2 times upper limit of normal (central laboratory)
- Impaired renal function, defined as serum-creatinine≥133μmol/L
- Uncontrolled treated/untreated severe hypertension (systolic blood pressure≥160mmHg and /or diastolic blood pressure≥95mmHg)
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 |
|---|---|---|
| Bifidobacterium viable pharmaceutics | Drug | Bifidobacterium viable pharmaceutics |
| Berberine Hydrochloride | Drug | Berberine Hydrochloride |
Primary outcome
Change in HbA1c from baseline to week 12
Time frame: Baseline and week 12
Change was measured at baseline and week 12 after randomization. Change was reported as the absolute difference in % HbA1c.
4 secondary outcomes
Percentage of subjects achieving HbA1c < 7% at week 12
Time frame: Week 12
Gut microbiome composition
Time frame: Baseline and week 12
Changes in postprandial glucagon-like peptide-1 (GLP-1) secretion between baseline and week 12
Time frame: Baseline and week 12
Adverse effects
Time frame: From baseline to week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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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.
Qiuhe Ji, Ph.D.,M.D. principal investigator
Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bifidobacterium viable pharmaceutics and Berberine Hydrochloride in people with Type 2 Diabetes Mellitus, run by Xijing Hospital at 4 sites 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 10 inclusion and 12 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: withdrawn, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in HbA1c from baseline to week 12 (time frame: Baseline and week 12). 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 14 Nov 2018.