Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT02084004
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02084004
Study Brief:
Protocol Section:
NCT02084004