Diabetes Mellitus, Type 2Phase 1NCT02750007
Tolerability to HS-20004 With Titration Administration in Type 2 Diabetic Patients
A Phase 1 study testing HS-20004 in people with Diabetes Mellitus, Type 2, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is conducted in China. The aim of this trial is to assess the tolerability to HS-20004 with titration administration in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- HS-20004
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Jan 2017
- 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
- Type 2 diabetes diagnosed for more than 3 months;
- HbA1c between ≥6.0 and ≤9.0 %, and FPG between ≥7.0 and ≤13.9 mmol/L;
- Body Mass Index (BMI) between 18.5 and 30 kg/m^2 (inclusive) with a total body weight of at least 50 kg;
- Agree to stop any other drugs for diabetes during washout and study period;
Who cannot join
- Treatment of GLP-1 analogues, DPP-IV enzyme inhibitors or other analogues before;
- History or family history of drug allergy;
- Smoker or alcohol abuse;
- Currently use or plan to use systemic corticosteroid;
- History of recurrent severe hypoglycemia;
- History of proliferative retinopathy or maculopathy which required acute treatment;
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- Impaired hepatic or renal function, or cardiac problem;
- Uncontrolled active or untreated hypertension;
- Family history of thyroid cancer or submandibular gland cancer, or past history of pancreatitis, cholelithiasis, or serious unconscious hypoglycemia history;
- Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
- Subject has participated in any investigational study within 3 months, or is currently participating in another clinical study;
- Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization; Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration;
- Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol；
- Subject was not used for the study as determined by the Investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Zhiguang Zhou, Professor, 0731-85292097, zhouzg@hotmail.com
About this study
Official title: Open-label, Non-randomized, Weekly-dose Titration Study to Assess the Tolerability to HS-20004 in Type 2 (Diabetes Mellitus) Diabetic Patients
This study is conducted in China. The aim of this trial is to assess the tolerability to HS-20004 with titration administration in type 2 diabetic patients.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- HS-20004
- 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.
HS-20004Drug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Weekly-dose titration from 0.04mg/day HS-20004 to the maximum tolerable dose or of the ultimate 0.18mg/day Receives: Drug: HS-20004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Adverse Events(TEAEs)
Measured: through study completion, an maximum of 8 weeks
Secondary outcomes (7)
Number of Nausea and vomiting during titration
Measured: through study completion, an maximum of 8 weeks
Mean Change From Baseline in Body Weight at different dose steps
Measured: through study completion, an maximum of 8 weeks
Change in plasma concentration of HS-20004 from baseline at different dose steps
Measured: through study completion, an maximum of 8 weeks
Change in plasma concentration of glucose from baseline at different dose steps
Measured: through study completion, an maximum of 8 weeks
Change in plasma concentration of insulin from baseline at different dose steps
Measured: through study completion, an maximum of 8 weeks
Change in plasma concentration of glucagon from baseline at different dose steps
Measured: through study completion, an maximum of 8 weeks
The minimum dose of HS-20004 that could keep plasma glucose under 6.1 mmol/L in Type 2 Diabetic Patients
Measured: through study completion, an maximum of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750007
- Sponsor's protocol ID
- HS-20004-Id
- Status last verified
- Apr 2016
- First submitted
- 11 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-randomized, Weekly-dose Titration Study to Assess the Tolerability to HS-20004 in Type 2 (Diabetes Mellitus) Diabetic Patients
- ClinicalTrials.gov ID
- NCT02750007
- Acronym / sponsor ID
- HS-20004-Id
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (estimated)
- First posted
- 25 Apr 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.
This study is conducted in China. The aim of this trial is to assess the tolerability to HS-20004 with titration administration in type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: HS-20004Weekly-dose titration from 0.04mg/day HS-20004 to the maximum tolerable dose or of the ultimate 0.18mg/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)
- Type 2 diabetes diagnosed for more than 3 months;
- HbA1c between ≥6.0 and ≤9.0 %, and FPG between ≥7.0 and ≤13.9 mmol/L;
- Body Mass Index (BMI) between 18.5 and 30 kg/m^2 (inclusive) with a total body weight of at least 50 kg;
- Agree to stop any other drugs for diabetes during washout and study period;
Key exclusion criteria (14 listed)
- Treatment of GLP-1 analogues, DPP-IV enzyme inhibitors or other analogues before;
- History or family history of drug allergy;
- Smoker or alcohol abuse;
- Currently use or plan to use systemic corticosteroid;
- History of recurrent 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 |
|---|---|---|
| HS-20004 | Drug | Experimental |
Primary outcome
Number of Treatment Emergent Adverse Events(TEAEs)
Time frame: through study completion, an maximum of 8 weeks
7 secondary outcomes
Number of Nausea and vomiting during titration
Time frame: through study completion, an maximum of 8 weeks
Mean Change From Baseline in Body Weight at different dose steps
Time frame: through study completion, an maximum of 8 weeks
Change in plasma concentration of HS-20004 from baseline at different dose steps
Time frame: through study completion, an maximum of 8 weeks
Change in plasma concentration of glucose from baseline at different dose steps
Time frame: through study completion, an maximum of 8 weeks
Change in plasma concentration of insulin from baseline at different dose steps
Time frame: through study completion, an maximum of 8 weeks
Change in plasma concentration of glucagon from baseline at different dose steps
Time frame: through study completion, an maximum of 8 weeks
The minimum dose of HS-20004 that could keep plasma glucose under 6.1 mmol/L in Type 2 Diabetic Patients
Time frame: through study completion, an maximum of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Individual participant dataSharing planned: No
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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 HS-20004 in people with Diabetes Mellitus, Type 2, run by Jiangsu Hansoh Pharmaceutical 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 4 inclusion and 14 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 25 Apr 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 Zhiguang - Zhou (0731-85292097, zhouzg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Emergent Adverse Events(TEAEs) (time frame: through study completion, an maximum of 8 weeks). 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 25 Apr 2016; AzTrials last refreshed its copy on 30 Oct 2026.