NCT02084004

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Longer than P75 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 27, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2.4 years

First QC Date

February 27, 2014

Last Update Submit

November 11, 2018

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitusBerberine HydrochlorideBifidobacterium

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and week 12

Secondary Outcomes (4)

  • Percentage of subjects achieving HbA1c < 7% at week 12

    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

  • Adverse effects

    From baseline to week 12

Study Arms (3)

Bifidobacterium viable pharmaceutics

EXPERIMENTAL

Bifidobacterium viable pharmaceutics, 2 Capsules, 2/day, 12 weeks

Drug: Bifidobacterium viable pharmaceutics

Berberine Hydrochloride

EXPERIMENTAL

Berberine Hydrochloride, 0.5g, 2/day, 12 weeks

Drug: Berberine Hydrochloride

lifestyle counseling

NO INTERVENTION

Interventions

Bifidobacterium viable pharmaceuticsDRUG
Bifidobacterium viable pharmaceutics
Berberine HydrochlorideDRUG
Berberine Hydrochloride

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained before any trial-related activities；
  • Male or female between 18 and 70 years of age
  • ≤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
  • %≤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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

The 323rd Hospital of People's Liberation Army

Xi'an, Shaanxi, 710054, China

Location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Qiuhe Ji, Ph.D.,M.D.

    Department of Endocrinology, Xijing Hospital, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 11, 2014

Study Start

November 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

CN(4)