Type 2 Diabetes
Conditions
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 .
Interventions
DRUGSP2086
the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The steady-state urine concentration (Css) of SP2086 acid | up to Day 13 | Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 |
| The maximum plasma concentration (Cmax) of SP2086 | up to Day 13 | Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086 |
| The steady-state plasma concentration (Css) of SP2086 | up to Day 13 | Css (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086 |
| The maximum plasma concentration (Cmax) of SP2086 acid | up to Day 13 | Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086 |
| The steady-state plasma concentration (Css) of SP2086 acid | up to Day 13 | Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 |
| The maximum urine concentration (Cmax) of SP2086 | up to Day 13 | Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086 |
| The steady-state urine concentration (Css) of SP2086 | up to Day 13 | Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086 |
| The maximum urine concentration (Cmax) of SP2086 acid | up to Day 13 | Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086 |
Secondary
| Measure | Time frame |
|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 13 |
Countries
China
Contacts
Primary ContactYanhua Ding, docter
Outcome results
None listed