Type 2 DiabetesPhase 1NCT02822534
The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients
A Phase 1 study testing SP2086 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SP2086
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Hosital of Jilin University
Changchun, Jilin
Yanhua Ding, docter, 0431-88782168, dingyanhua2003@126.com
About this study
Official title: 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 .
- Conditions
- Type 2 Diabetes
- Being tested
- SP2086
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP2086Drug
the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.
| Study group | Role | What they receive |
|---|---|---|
| SP2086 50mg | Experimental | 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. Receives: Drug: SP2086 |
| SP2086 100mg | Experimental | 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. Receives: Drug: SP2086 |
| SP2086 200mg | Experimental | 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. Receives: Drug: SP2086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to Day 13
Secondary outcomes (1)
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822534
- Sponsor's protocol ID
- SP2086-113
- Status last verified
- Mar 2016
- First submitted
- 30 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Pharmacokinetics,Pharmacodynamics,Safety and Tolerability Study Following Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT02822534
- Acronym / sponsor ID
- SP2086-113
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (estimated)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SP2086 50mg | Experimental | Drug: SP2086there 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. |
| SP2086 100mg | Experimental | Drug: SP2086there 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. |
| SP2086 200mg | Experimental | Drug: SP2086there 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP2086the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively. | Drug | SP2086 100mg, SP2086 200mg, SP2086 50mg |
Primary outcome
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
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
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
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
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
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
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
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
1 secondary outcome
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SP2086 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhua Ding, docter (0431-88782168, dingyanhua2003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum plasma concentration (Cmax) of SP2086 (time frame: up to Day 13). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.