Clinical trial NCT02822534: The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients
Official title: the Pharmacokinetics,Pharmacodynamics,Safety and Tolerability Study Following Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 .


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.

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SP2086
timeFrame: up to Day 13
measure: The steady-state plasma concentration (Css) of SP2086
timeFrame: up to Day 13
measure: The maximum plasma concentration (Cmax) of SP2086 acid
timeFrame: up to Day 13
measure: The steady-state plasma concentration (Css) of SP2086 acid
timeFrame: up to Day 13
measure: The maximum urine concentration (Cmax) of SP2086
timeFrame: up to Day 13
measure: The steady-state urine concentration (Css) of SP2086
timeFrame: up to Day 13
measure: The maximum urine concentration (Cmax) of SP2086 acid
timeFrame: up to Day 13
measure: The steady-state urine concentration (Css) of SP2086 acid
timeFrame: up to Day 13
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 13
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hosital of Jilin University
state: Jilin
Study officials:
References: