A Study of Supaglutide in Chinese Type 2 Diabetes Patients
NCT ID: NCT04314622
Last Updated: 2021-09-17
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
40 participants
INTERVENTIONAL
2020-04-14
2021-03-16
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.
A Study of the Efficacy and Safety of Supaglutide in Healthy Participants
NCT03745885
A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes
NCT04591626
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
NCT04965506
Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
NCT04466904
Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus
NCT05268237
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
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Supaglutide (Part A)
Four investigational doses of Supaglutide administered weekly (or bi-weekly) and subcutaneously (SC) in T2DM patients.
Supaglutide
Administered SC
Placebo(Part A)
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
Placebo
Administered SC
Supaglutide (Part B)
Two investigational doses of Supaglutide administered weekly (or bi-weekly) and SC in T2DM patients.
Supaglutide
Administered SC
Placebo (Part B)
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
Placebo
Administered SC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Supaglutide
Administered SC
Placebo
Administered SC
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
2. Have diet and exercise intervention only (for part A and part B) or been treated with stable dose of metformin as monotherapy for at least 3 months (for part B only)
3. Have HbA1c ≥7.0% and ≤10.0% as assessed by the central laboratory.
4. Have a body mass index (BMI) of 20-40 kilograms per square meter (kg/m\^2).
Exclusion Criteria
2. Evidences of fasting C-peptide levels\<0.81 ng/mL.
3. History of trauma, infection or surgery within a month;
4. History of blood donation, blood transfusion or losing more than 450 ml blood within 3 months.
5. History of the severe cardiovascular conditions, gastrointestinal diseases, blood system diseases, pancreatitis, or malignant tumors.
6. Evidence of abnormal thyroid function within 6 months before screening.
7. Positive test results in HBsAg, HCVAB, HIVAB or TPAB.
8. History of serious mental illness.
9. History of drug or alcohol abuse.
10. History of a transplanted organ, acquired or congenital immune system diseases.
11. Allergy to active ingredients or excipients of the test drug.
12. Evidence of abnormal result of laboratory examination according to the judgment of researchers.
13. Participated in any interventional medical, surgical, or pharmaceutical study within 3 months prior to entry into the study.
14. Previously completed or withdrawn from this study after providing informed consent.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai 6th People's Hospital
OTHER
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Weiping Jia, Doctor
Role: PRINCIPAL_INVESTIGATOR
Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital
Yuqian Bao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lou YR, Xu YL, Xiong Y, Deng C, Wang Q. Population Pharmacokinetics of Efsubaglutide Alfa in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2025 Apr;64(4):533-552. doi: 10.1007/s40262-025-01475-7. Epub 2025 Feb 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YN011B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.