The Drug-drug Interaction of SP2086 and Metformin

A Phase 1 study testing SP2086 and Metformin in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is an open single and self-control study,planning to recruit 24 cases of healthy male volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and Metformin. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes
What is being tested?: SP2086 and Metformin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Dec 2015to Mar 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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2,weight among of 50-100kg.
willing to using contraception during the study and after the 6 months.

Who cannot join

History of diabetes
History of heart failure or renal insufficiency
Urinary tract infections, or vulvovaginal mycotic infections
History of or current clinically significant medical illness as determined by the Investigator
History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
Known allergy to SP2086 or metformin or any of the excipients of the formulation of SP2086 or metformin

About this study

Conditions: Type 2 Diabetes
Being tested: SP2086, Metformin
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
MetforminDrug

Study groups in NCT02813863
Study group	Role	What they receive
SP2086 and Metformin	Experimental	In the first day,the subject takes metformin 1000mg once,and from Day 4 to Day 7 they need to take SP2086 100mg everyday. In Day 8,they will be given SP2086 100mg and metformin 1000mg. Receives: Drug: SP2086; Drug: Metformin

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 metformin
Measured: up to Day 9
The area under the plasma concentration-time curve (AUC) of SP2086
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of metformin
Measured: up to Day 9
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 metformin
Measured: up to Day 9
The area under the plasma concentration-time curve (AUC) of SP2086 acid
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of metformin
Measured: up to Day 9
The maximum plasma concentration (Cmax) of Metformin
Cmax (a measure of the body's exposure to metformin) will be compared. before and after administration of multiple doses of SP2086
Measured: up to Day 9
The area under the plasma concentration-time curve (AUC) of metformin
AUC (a measure of the body's exposure to metformin) will be compared before and after administration of multiple doses of SP2086
Measured: up to Day 9

Secondary outcomes (1)

The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Mar 2016

First posted27 Jun 2016 (estimated)
Study startDec 2015
Primary completionMar 2016

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02813863
Sponsor's protocol ID: SP2086-104
Status last verified: Dec 2015
First submitted: 23 Jun 2016
Last updated: 27 Jun 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Drug-drug Interaction of SP2086 and Metformin
ClinicalTrials.gov ID: NCT02813863
Acronym / sponsor ID: SP2086-104
Conditions: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2015
Primary completion: Mar 2016 (actual)
First posted: 27 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SP2086 and Metformin	Experimental	Drug: SP2086, Drug: MetforminIn the first day,the subject takes metformin 1000mg once,and from Day 4 to Day 7 they need to take SP2086 100mg everyday. In Day 8,they will be given SP2086 100mg and metformin 1000mg.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2,weight among of 50-100kg.
willing to using contraception during the study and after the 6 months.

Key exclusion criteria (6 listed)

History of diabetes
History of heart failure or renal insufficiency
Urinary tract infections, or vulvovaginal mycotic infections
History of or current clinically significant medical illness as determined by the Investigator
History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose

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
SP2086	Drug	SP2086 and Metformin
Metformin	Drug	SP2086 and Metformin

Primary outcome

The maximum plasma concentration (Cmax) of SP2086
Time frame: up to Day 9
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of metformin
The area under the plasma concentration-time curve (AUC) of SP2086
Time frame: up to Day 9
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of metformin
The maximum plasma concentration (Cmax) of SP2086 acid
Time frame: up to Day 9
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of metformin
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time frame: up to Day 9
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of metformin
The maximum plasma concentration (Cmax) of Metformin
Time frame: up to Day 9
Cmax (a measure of the body's exposure to metformin) will be compared. before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of metformin
Time frame: up to Day 9
AUC (a measure of the body's exposure to metformin) 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 9

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SP2086 and Metformin in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..

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 2 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 9). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02813863.

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 27 Jun 2016.