Type 2 DiabetesPhase 1NCT02354027
The Drug-drug Interaction of SHR3824 and Metformin
A Phase 1 study testing SHR3824 metformin in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers. 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?
- SHR3824 metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jan 2015
- 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 24 kg/m2.
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 SHR3824 or metformin or any of the excipients of the formulation of SHR3824 or metformin
About this study
Official title: Drug Interaction Study of Henagliflozin and Metformin in Healthy Subjects
The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.
Read the detailed description
This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and metformin in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. SHR3824 will be administered orally (by mouth) as 25 mg on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on Days 1 and 8. Both SHR3824 and metformin tablets will be taken with 8 ounces (240 mL) of water.
- Conditions
- Type 2 Diabetes
- Being tested
- SHR3824 metformin
- Keywords
- SHR3824 metformin 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.
SHR3824 metforminDrug
Also called Henagliflozin metformin
Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8.
Drug: SHR3824 + Metformin
| Study group | Role | What they receive |
|---|---|---|
| SHR3824 25mg/metformin 1000mg | Experimental | Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8. Receives: Drug: SHR3824 metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax) of SHR3824.
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.
Measured: At protocol-specified times up to Day 9.
The area under the plasma concentration-time curve (AUC) of SHR3824.
AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.
Measured: At protocol-specified times 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 SHR3824
Measured: At protocol-specified times 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 SHR3824.
Measured: At protocol-specified times up to Day 9.
Secondary outcomes (1)
The number of volunteers with adverse events as a measure of safety and tolerability.
Measured: Up tp day 9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionJan 2015
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
- 12 participants (actual)
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
- NCT02354027
- Sponsor's protocol ID
- SHR3824-105
- Status last verified
- Jan 2015
- First submitted
- 29 Jan 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interaction Study of Henagliflozin and Metformin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02354027
- Acronym / sponsor ID
- SHR3824-105
- Conditions
- Type 2 Diabetes
- Keywords
- SHR3824 metformin drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Feb 2015 (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.
The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.
Detailed description
This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and metformin in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. SHR3824 will be administered orally (by mouth) as 25 mg on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on Days 1 and 8. Both SHR3824 and metformin tablets will be taken with 8 ounces (240 mL) of water.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR3824 25mg/metformin 1000mg | Experimental | Drug: SHR3824 metforminTwo 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 24 kg/m2.
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 |
|---|---|---|
| SHR3824 metforminAlso: Henagliflozin metforminTwo 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8. Drug: SHR3824 + Metformin | Drug | SHR3824 25mg/metformin 1000mg |
Primary outcome
The maximum plasma concentration (Cmax) of SHR3824.
Time frame: At protocol-specified times up to Day 9.
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.
The area under the plasma concentration-time curve (AUC) of SHR3824.
Time frame: At protocol-specified times up to Day 9.
AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.
The maximum plasma concentration (Cmax) of metformin.
Time frame: At protocol-specified times 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 SHR3824
The area under the plasma concentration-time curve (AUC) of metformin
Time frame: At protocol-specified times 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 SHR3824.
1 secondary outcome
The number of volunteers with adverse events as a measure of safety and tolerability.
Time frame: Up tp 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 16 Jul 2015.
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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.
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 SHR3824 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 1 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 16 Jul 2015. 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 SHR3824. (time frame: At protocol-specified times up to Day 9.). The study lists 4 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 16 Jul 2015.