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

NCT ID: NCT02822534

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30

Brief 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 .

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SP2086 50mg

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.

Group Type: EXPERIMENTAL

SP2086

Intervention Type: DRUG

the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.

SP2086 100mg

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.

Group Type: EXPERIMENTAL

SP2086

Intervention Type: DRUG

the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.

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.

Group Type: EXPERIMENTAL

SP2086

Intervention Type: DRUG

the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.

Interventions

SP2086

the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Hosital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanhua Ding, docter

Role: CONTACT

dingyanhua2003@126.com

0431-88782168

Facility Contacts

Yanhua Ding, docter

Role: primary

dingyanhua2003@126.com

0431-88782168

Other Identifiers

SP2086-113

Identifier Type: -

Identifier Source: org_study_id