A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
NCT ID: NCT03848793
Last Updated: 2022-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
128 participants
INTERVENTIONAL
2019-03-06
2020-12-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Experiment of Noiiglutide Injection in Type 2 Diabetes Patients
NCT06649773
A Study of HS-20094 in T2DM Participants
NCT06118008
Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects
NCT06688123
Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
NCT06148649
A Study of TG103 Injection in Type 2 Diabetes Subjects
NCT05348122
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HS-20004 or placebo treatment (Low dose)
HS-20004 or placebo SC once daily (Low dose)
HS-20004
treatment
HS-20004 or placebo treatment (median dose 1)
HS-20004 or placebo SC once daily (median dose 1)
HS-20004
treatment
HS-20004 or placebo treatment (median dose 2)
HS-20004 or placebo SC once daily (median dose 2)
HS-20004
treatment
HS-20004 or placebo treatment (high dose)
HS-20004 or placebo SC once daily (high dose)
HS-20004
treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HS-20004
treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HbA1c between 7.5 and 11.0 % (inclusive), and FPG ≥9.0mmol/l
* Body Mass Index (BMI) between 23 and 35 kg/m2(inclusive)
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HS-20004-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.