The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes
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.
Sites / Locations
- the First Hosital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
SP2086 50mg
SP2086 100mg
SP2086 200mg
there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 8 Type 2 diabetes patients.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.
there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 8 Type 2 diabetes patients.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.
there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 8 Type 2 diabetes patients.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.