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Type 2 DiabetesPhase 1NCT02815787

The Drug -Drug Interaction of SP2086 and Glyburide

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

Completed

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

Official record
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Trial summary

The purpose of the study is to investigate the potential interaction between SP2086 and Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers respectively. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
SP2086 and Glyburide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
Mar 2014to Jul 2014
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
  • Had signed the informed consent himself or herself.

Who cannot join

  • Have the abnormal lab or other examination results and the change have clinical significance.
  • Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide.
  • History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs.
  • History of severe unconsciousness hypoglycemia
  • History of any surgery prior to screening in 6 months.
  • History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month.
Show all 12Show fewer
  • History of participate any drug or medical device prior to screening in 3 months.
  • Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins).
  • 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion.
  • The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive.
  • Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
  • Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

Other trials in China

About this study

Official title: A Single Randomized, Open, Cross-over, Phase Ie Study to Access the Drug-drug Interaction of SP2086 and Glyburide

The purpose of the study is to investigate the potential interaction between SP2086 and Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers respectively.

Read the detailed description

This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Glyburide in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences.The A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8; Glyburide will be administered orally (by mouth) as 200mg on Days 8.

Conditions
Type 2 Diabetes
Being tested
SP2086, Glyburide
Keywords
SP2086, Glyburide, drug-drug interaction
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

    In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.

  • GlyburideDrug

    In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.

Study groups in NCT02815787
Study groupRoleWhat they receive
SP2086 and GlyburideActive comparatorThe A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.The trial period were 25 days. In this group,the subjects was given the drugs from A sequence to the B sequence.
Receives: Drug: SP2086; Drug: Glyburide
Glyburide and SP2086Active comparatorThe A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.The trial period were 25 days.In this group,the subjects was given the drugs from B sequence to the A sequence.
Receives: Drug: SP2086; Drug: Glyburide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 multiple doses of SP2086

    Measured: up to Day 25

  2. 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 multiple doses of SP2086

    Measured: up to Day 25

  3. The maximum plasma concentration (Cmax) of Glyburide

    Cmax (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide

    Measured: up to Day 25

  4. 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 multiple doses of SP2086

    Measured: up to Day 25

  5. 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 multiple doses of SP2086

    Measured: up to Day 25

  6. The area under the plasma concentration-time curve (AUC) of Glyburide

    AUC (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide

    Measured: up to Day 25

Secondary outcomes (1)

  1. The number of volunteers with adverse events as a measure of safety and tolerability

    Measured: up to Day 25

Timeline

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

  1. First posted28 Jun 2016 (estimated)
  2. Study startMar 2014
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02815787
Sponsor's protocol ID
QLHCPI-179
Status last verified
Jun 2016
First submitted
3 Jan 2016
Last updated
28 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SP2086 and Glyburide 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 2 inclusion and 12 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 28 Jun 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?

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 25). 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 NCT02815787.

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 28 Jun 2016.

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