The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SP2086 in Type 2 Diabetes Patients .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.