Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
NCT ID: NCT03987308
Last Updated: 2025-05-02
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.
RECRUITING
NA
115 participants
INTERVENTIONAL
2019-07-02
2025-12-31
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.
Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus
NCT03829891
Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes
NCT05667220
Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
NCT03563794
A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes
NCT04017832
Sitagliptin for the Treatment of Type 2 Diabetes
NCT04495881
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a national-level, multicenter, randomized, open study with parallel controls. The study consists of two phases:
a 8-week treatment phase and a 12-week post-treatment follow-up period.
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
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Continuous Beinaglutide infusion
8-week Beinaglutide (continuous subcutaneous infusion) treatment group
Beinaglutide
Beinaglutide (continuous subcutaneous infusion)
Continuouns Insulin aspart infusion
8-week insulin aspart (CSII) treatment group
Insulin aspart
Insulin aspart (CSII)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Beinaglutide
Beinaglutide (continuous subcutaneous infusion)
Insulin aspart
Insulin aspart (CSII)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Voluntary signing of the informed consent form.
3. Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year.
4. HbA1c between 7.5% and 10.0%.
5. BMI between 24 kg/m² and 42 kg/m².
6. Subjects who have not taken antidiabetic medications or have used oral antidiabetic medications for less than 3 months and have discontinued for more than 1 month (calculated from the date of signing the informed consent form).
7. Subjects with reproductive potential (including male subjects whose partners have reproductive potential) agree to use effective contraception during the study and for 1 month after study completion.
Exclusion Criteria
2. History of obstructive intestinal diseases or potential complications: subjects with post-abdominal surgery or peritoneal infection-related intestinal adhesions, intestinal obstruction sequelae; subjects with intestinal motility disorders, chronic constipation; subjects with a history of Crohn's disease or ulcerative colitis.
3. History of pancreatitis.
4. Family history of medullary thyroid carcinoma.
5. History of malignant tumors.
6. ALT, AST \>3 times the upper limit of normal, and/or total bilirubin \>2 times the upper limit of normal.
7. Moderate to severe renal insufficiency (eGFR \<60 ml/min/1.73m²).
8. Triglycerides ≥5.0 mmol/L.
9. Multiple endocrine neoplasia type 2 (MEN 2).
10. Participation in any pre-marketing drug study within 3 months.
11. Use or expected use of systemic corticosteroids, immunosuppressants, or cytotoxic drugs during the study period.
12. History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months prior to screening.
13. Blood pressure exceeding the following criteria (untreated or treated): systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
14. History of any of the following cardiovascular diseases within 3 months prior to screening: acute myocardial infarction, New York Heart Association functional class III/IV heart failure or left ventricular ejection fraction ≤40%, or cerebrovascular event (stroke).
15. Allergy to binaclotide or any component of the study drug, or allergy to insulin or any component of the insulin used in the study.
16. Presence of other severe diseases that may interfere with the study, as judged by the investigator.
17. Pregnant or breastfeeding women.
18. Poor compliance, as judged by the investigator, and inability to complete the study as required.
19. Inability to undergo continuous pump infusion: subjects allergic to subcutaneous infusion tubes or adhesive tape; subjects unwilling to have long-term subcutaneous infusion tubes or continuous pump use; subjects with psychological aversion to pump therapy; subjects or their families lack relevant knowledge and are unable to master the use after training; subjects with severe psychological disorders or mental abnormalities; subjects who are unable to care for themselves and have no caregivers.
20. Any other factors deemed unsuitable for participation in the study by the investigator.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Hospital
OTHER_GOV
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.
Pinggu District Hospital
Beijing, Beijing Municipality, China
Capital Medical University Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Emergency General Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Harbin Medical University Second Hospital
Harbin, Heilongjiang, China
Southeast University Zhongda Hospital
Nanjing, Jiangsu, China
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Jilin University Second Hospital
Changchun, Jilin, China
Xi'an Jiaotong University Second Hospital
Xi'an, Shaanxi, China
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, China
Peking University Binhai Hospital
Tianjin, Tianjin Municipality, China
First Hospital of Peking University
Beijing, , China
Heilongjiang provincial hospital
Harbin, , China
Henan People's Hospital
Zhengzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Binhong Duan, M.D, Ph.D.
Role: primary
Huijuan Yuan, Ph.D. M.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BN-IIT-IS-008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.