Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment：an Open-label, Multicenter，Randomized, Prospective，Controlled Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Locations
- 4
- Primary Endpoint
- Change in HbA1c from baseline to week 12
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%
- •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
Exclusion Criteria
- •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
- •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
Arms & Interventions
Bifidobacterium viable pharmaceutics
Bifidobacterium viable pharmaceutics, 2 Capsules, 2/day, 12 weeks
Intervention: Bifidobacterium viable pharmaceutics (Drug)
Berberine Hydrochloride
Berberine Hydrochloride, 0.5g, 2/day, 12 weeks
Intervention: Berberine Hydrochloride (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of subjects achieving HbA1c < 7% at week 12(Week 12)
- Adverse effects(From baseline to week 12)
- Gut microbiome composition(Baseline and week 12)
- Changes in postprandial glucagon-like peptide-1 (GLP-1) secretion between baseline and week 12(Baseline and week 12)