Type 2 DiabetesPhase 1NCT02386982
Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients
A Phase 1 study testing HMS5552 in people with Type 2 Diabetes, run by Hua Medicine Limited at 1 site in China.
Trial summary
This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HMS5552
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female,age 18-65 years
- Has type 2 diabetes mellitus
- BMI 20 to 29kg/m2
- Willingness to adhere to the protocol requirement
Who cannot join
- Patients with type1 diabetes mellitus
- Received any antidiabetic drug within run-in or during screening
- Hepatic diseases
- Kidney diseases
- Clinical abnormal finding in EVG,labs and physical exams
- Women of child-bearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomized, Open-label, 2-arm, 4-week Treatment Study to Investigate the Beta Cell Function and Related Pharmacodynamics in Type 2 Diabetes Mellitus (T2DM) Patients
This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.
- Conditions
- Type 2 Diabetes
- Being tested
- HMS5552
- 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.
HMS5552Drug
Also called Sinogliatin
| Study group | Role | What they receive |
|---|---|---|
| HMS5552 dose 1 | Experimental | HMS5552 75mg.Oral administration,twice per day. Receives: Drug: HMS5552 |
| HMS5552 dose 2 | Experimental | HMS5552 75mg.Oral administration,once per day. Receives: Drug: HMS5552 |
What is being measured
The primary outcome is the main question the study is designed to answer.
beta cell function
will be assessed by change of beta cell function index
Measured: 4 weeks
HbA1
Measured: 4 weeks
24-hour glucose change
Measured: 4 weeks
Secondary outcomes (2)
The study drug concentration in blood samples to be collected after drug administration
Measured: 4 weeks
Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386982
- Sponsor's protocol ID
- HMM0103
- Status last verified
- May 2015
- First submitted
- 5 Mar 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomized, Open-label, 2-arm, 4-week Treatment Study to Investigate the Beta Cell Function and Related Pharmacodynamics in Type 2 Diabetes Mellitus (T2DM) Patients
- ClinicalTrials.gov ID
- NCT02386982
- Acronym / sponsor ID
- HMM0103
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Mar 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.
This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMS5552 dose 1 | Experimental | Drug: HMS5552HMS5552 75mg.Oral administration,twice per day. |
| HMS5552 dose 2 | Experimental | Drug: HMS5552HMS5552 75mg.Oral administration,once per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female,age 18-65 years
- Has type 2 diabetes mellitus
- BMI 20 to 29kg/m2
- Willingness to adhere to the protocol requirement
Key exclusion criteria (6 listed)
- Patients with type1 diabetes mellitus
- Received any antidiabetic drug within run-in or during screening
- Hepatic diseases
- Kidney diseases
- Clinical abnormal finding in EVG,labs and physical exams
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 |
|---|---|---|
| HMS5552Also: Sinogliatin | Drug | HMS5552 dose 1, HMS5552 dose 2 |
Primary outcome
beta cell function
Time frame: 4 weeks
will be assessed by change of beta cell function index
HbA1
Time frame: 4 weeks
24-hour glucose change
Time frame: 4 weeks
2 secondary outcomes
The study drug concentration in blood samples to be collected after drug administration
Time frame: 4 weeks
Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement
Time frame: 4 weeks
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 14 May 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.
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 HMS5552 in people with Type 2 Diabetes, run by Hua Medicine Limited 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 4 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 14 May 2015. 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?
beta cell function (time frame: 4 weeks). The study lists 3 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 14 May 2015.