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

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