Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment

• Status: Withdrawn
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital

Criteria

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