Diabetes Mellitus, Type 2Phase 2NCT03848793
A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
A Phase 2 study testing HS-20004 in people with Diabetes Mellitus, Type 2, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- HS-20004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2019to 14 Dec 2020
- Phase
- Phase 2
- 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 70 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 7.5 and 11.0 % (inclusive), and FPG ≥9.0mmol/l
- Body Mass Index (BMI) between 23 and 35 kg/m2(inclusive)
Who cannot join
- History or family history of drug allergy
- Subjects treated with any other anti-diabetes drug within 8 weeks before screening
- Participation in any other clinical trial of an investigational medicinal product within 3 months before screening
- Smoker or alcohol abuse
- Currently use or plan to use systemic corticosteroid
- History of recurrent severe hypoglycemia
Show all 14Show fewer
- Type 1 diabetes or secondary diabetes mellitus
- Uncontrolled active or untreated hypertension
- History of pancreatitis (acute or chronic)
- Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
- Serious unconscious hypoglycemia history
- Within the past 6 months before screening any of the following: coronary artery revascularization, patients presently classified as being in New York Heart Association (NYHA) Class III or IV, myocardial infarction, stroke or unstable angina and/or persistent and clinically significant arrhythmias
- 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
- Subject was not used for the study as determined by the Investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: A Phase 2, Multiple Centers, Double-blind, Placebo-Controlled, Randomised Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
The study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks.
- 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
Also called Noiiglutide Injection
treatment
| Study group | Role | What they receive |
|---|---|---|
| HS-20004 or placebo treatment (Low dose) | Other | HS-20004 or placebo SC once daily (Low dose) Receives: Drug: HS-20004 |
| HS-20004 or placebo treatment (median dose 1) | Other | HS-20004 or placebo SC once daily (median dose 1) Receives: Drug: HS-20004 |
| HS-20004 or placebo treatment (median dose 2) | Other | HS-20004 or placebo SC once daily (median dose 2) Receives: Drug: HS-20004 |
| HS-20004 or placebo treatment (high dose) | Other | HS-20004 or placebo SC once daily (high dose) Receives: Drug: HS-20004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Estimated mean change from baseline in HbA1c at week 16. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product
Measured: 16 weeks treatment
Secondary outcomes (2)
Change in Fasting Plasma Glucose
Estimated mean change from baseline in FPG at week 16.
Measured: 16 weeks treatment
Change in Body Weight
Estimated mean change from baseline in Body Weigh at week 16.
Measured: 16 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start6 Mar 2019
- Primary completion4 Jun 2020
- Study completion14 Dec 2020
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 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
- NCT03848793
- Sponsor's protocol ID
- HS-20004-201
- Status last verified
- Nov 2022
- First submitted
- 19 Feb 2019
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multiple Centers, Double-blind, Placebo-Controlled, Randomised Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
- ClinicalTrials.gov ID
- NCT03848793
- Acronym / sponsor ID
- HS-20004-201
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- 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 study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HS-20004 or placebo treatment (Low dose) | Other | Drug: HS-20004HS-20004 or placebo SC once daily (Low dose) |
| HS-20004 or placebo treatment (median dose 1) | Other | Drug: HS-20004HS-20004 or placebo SC once daily (median dose 1) |
| HS-20004 or placebo treatment (median dose 2) | Other | Drug: HS-20004HS-20004 or placebo SC once daily (median dose 2) |
| HS-20004 or placebo treatment (high dose) | Other | Drug: HS-20004HS-20004 or placebo SC once daily (high dose) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes diagnosed for more than 3 months
- HbA1c between 7.5 and 11.0 % (inclusive), and FPG ≥9.0mmol/l
- Body Mass Index (BMI) between 23 and 35 kg/m2(inclusive)
Key exclusion criteria (14 listed)
- History or family history of drug allergy
- Subjects treated with any other anti-diabetes drug within 8 weeks before screening
- Participation in any other clinical trial of an investigational medicinal product within 3 months before screening
- Smoker or alcohol abuse
- Currently use or plan to use systemic corticosteroid
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-20004Also: Noiiglutide Injectiontreatment | Drug | HS-20004 or placebo treatment (Low dose), HS-20004 or placebo treatment (high dose), HS-20004 or placebo treatment (median dose 1), HS-20004 or placebo treatment (median dose 2) |
Primary outcome
HbA1c
Time frame: 16 weeks treatment
Estimated mean change from baseline in HbA1c at week 16. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product
2 secondary outcomes
Change in Fasting Plasma Glucose
Time frame: 16 weeks treatment
Change in Body Weight
Time frame: 16 weeks treatment
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 7 Nov 2022.
- 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.
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 2 study testing HS-20004 in people with Diabetes Mellitus, Type 2, 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 3 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: finished, as of the sponsor's last update on 7 Nov 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
HbA1c (time frame: 16 weeks treatment). 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 7 Nov 2022.