Compares two treatments for newly diagnosed type 2 diabetes in adults
Tests beinaglutide injection against insulin infusion in adults newly diagnosed with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
Key facts
- Where
- Beijing, Changchun, Guangzhou, Harbin, Luzhou, Nanjing, Tianjin, Xi'an, Xuzhou, and Zhengzhou, ChinaSee the 16 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT03987308, who can take part
Where in China
- Capital Medical University Beijing Anzhen HospitalBeijing, ChinaTaking people
- Emergency General HospitalBeijing, ChinaTaking people
- First Hospital of Peking UniversityBeijing, ChinaTaking people
- Peking University Shougang HospitalBeijing, ChinaTaking people
- Pinggu District HospitalBeijing, ChinaTaking people
- China-Japan Union Hospital of JiLin UniversityChangchun, ChinaTaking people
- Jilin University Second HospitalChangchun, ChinaTaking people
- Southern Medical University Nanfang HospitalGuangzhou, ChinaTaking people
- Harbin Medical University Second HospitalHarbin, ChinaTaking people
- Heilongjiang Provincial HospitalHarbin, ChinaTaking people
- Southwest Medical University Affiliated HospitalLuzhou, ChinaTaking people
- Southeast University Zhongda HospitalNanjing, ChinaTaking people
- Peking University BinHai HospitalTianjin, ChinaTaking people
- Xi'an Jiaotong University Second HospitalXi'an, ChinaTaking people
- Xuzhou Medical University Affiliated HospitalXuzhou, ChinaTaking people
- Henan People's HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Hospital
- Trial code
- NCT03987308
- Record updated
- 2 May 2025
- Original description
The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.Read full original descriptionShow less
Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Treatment of Patients With Newly Diagnosed Type 2 Diabetes: a Multicenter, Randomized Open Trial Study With Parallel Controls
The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.
Inclusion: Age 18 to 70 years (inclusive) at enrollment, regardless of gender; Voluntary signing of the informed consent form; Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year; HbA1c between 7.5% and 10.0%; BMI between 24 kg/m² and 42 kg/m²; 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); 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: Participation in any pre-marketing drug study within 3 months; Use or expected use of systemic corticosteroids, immunosuppressants, or cytotoxic drugs during the study period; History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months prior to screening; Patients with type 1 diabetes or other types of diabetes; 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; History of pancreatitis; Family history of medullary thyroid carcinoma; History of malignant tumors; Allergy to binaclotide or any component of the study drug, or allergy to insulin or any component of the insulin used in the study; Presence of other severe diseases that may interfere with the study, as judged by the investigator; 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; ALT, AST >3 times the upper limit of normal, and/or total bilirubin >2 times the upper limit of normal; Moderate to severe renal insufficiency (eGFR <60 ml/min/1.73m²); Triglycerides ≥5.0 mmol/L; 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); Multiple endocrine neoplasia type 2 (MEN 2); Blood pressure exceeding the following criteria (untreated or treated): systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; Pregnant or breastfeeding women; Poor compliance, as judged by the investigator, and inability to complete the study as required; Any other factors deemed unsuitable for participation in the study by the investigator.