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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02822534
Eligibility Criteria:
Inclusion Criteria:
* The patient has a definitive diagnosis of Type 2 Diabetes.
* BMI(a measure of a person's weight in relation to height)is between 19 and 30 kg/m2,and the weight is equal or greater than 50kg.
* Never use the antidiabetic or only use one type oral antidiabetic(except the insulin secretagogues agent).
* The patient never use insulin in 3 months of screening.
* Be willing to accept physical contraception.
* Sign the informed consents voluntarily and ensure to completed the study.
Exclusion Criteria:
* The value of fasting blood-glucose(FBG)\>13.9mmol/L,or HbA1c\>10.0%;
* Known allergy to SP2086 or any of the excipients of the formulation of SP2086;
* Type 1 diabetes,or Gestational diabetes,or other type diabetes;
* ever occured acute complications of diabetes such as diabetic ketoacidosis,high permeability syndrome or lactic acidosis.
* ever occured the severe hypoglycemia.
* History of chronic complication of diabetes(kidney disease,or retinopathy,neuropathy,or lower limb vascular lesion).
* The value of serum creatinine over the upper limit of normal range.
* ever occured myocardial infarction,acute coronary syndrome, transient ischemic attack.
* QTc interval\>450ms(male) or \>470ms(female) or have the history of cardiac insufficiency which the NYHA(New York Heart Association) class over I degree.
* have the history of hypertension,and not well control:SBP(Systolic Blood Pressure)\>140 mmHg or DBP(Diastolic Blood Pressure)\>90 mmHg.
* have the history of cancer.
* the value of ALT and/or AST was greater two times of upper limit of normal range,or the STB over the 1.5 times of upper limit of normal range.
* the B hepatitis surface antigen or hepatitis C antibody or syphilis antibody or HIV antibody was positive.
* had participated three or more clinical trial in one year or had participated one time clinical medicine in one month of screening.
* have the history of blood donation in 3 months of screening or received the blood transfusion in 1 months of screening.
* have the history of tobacco,alcohol or drug abuse.
* History of or current clinically significant medical illness as determined by the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02822534
Study Brief:
Protocol Section:
NCT02822534