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

the Pharmacokinetics,Pharmacodynamics,Safety and Tolerability Study Following Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients

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 .

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: SP2086

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yanhua Ding, docter; Phone Number: 0431-88782168; Email: dingyanhua2003@126.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • the First Hosital of Jilin University
      • Contact: Yanhua Ding, docter; Phone Number: 0431-88782168; Email: dingyanhua2003@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: SP2086; the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.
Experimental: 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.	Drug: SP2086; the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.
Experimental: 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.	Drug: SP2086; the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum plasma concentration (Cmax) of SP2086	Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086	up to Day 13
The steady-state plasma concentration (Css) of SP2086	Css (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086	up to Day 13
The maximum plasma concentration (Cmax) of SP2086 acid	Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086	up to Day 13
The steady-state plasma concentration (Css) of SP2086 acid	Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086	up to Day 13
The maximum urine concentration (Cmax) of SP2086	Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086	up to Day 13
The steady-state urine concentration (Css) of SP2086	Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086	up to Day 13
The maximum urine concentration (Cmax) of SP2086 acid	Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086	up to Day 13
The steady-state urine concentration (Css) of SP2086 acid	Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086	up to Day 13

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 13

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Estimate): July 4, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SP2086-113