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

June 30, 2016 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • the First Hosital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The maximum plasma concentration (Cmax) of SP2086
Time Frame: 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
up to Day 13
The steady-state plasma concentration (Css) of SP2086
Time Frame: 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
up to Day 13
The maximum plasma concentration (Cmax) of SP2086 acid
Time Frame: 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
up to Day 13
The steady-state plasma concentration (Css) of SP2086 acid
Time Frame: 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
up to Day 13
The maximum urine concentration (Cmax) of SP2086
Time Frame: 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
up to Day 13
The steady-state urine concentration (Css) of SP2086
Time Frame: 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
up to Day 13
The maximum urine concentration (Cmax) of SP2086 acid
Time Frame: 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
up to Day 13
The steady-state urine concentration (Css) of SP2086 acid
Time Frame: 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
up to Day 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame: up to Day 13
up to Day 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP2086-113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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